Trial record 1 of 3 for:
TOPCAT
Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (TOPCAT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by New England Research Institutes.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
New England Research Institutes
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00094302
First received: October 15, 2004
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Heart Diseases Heart Failure, Congestive |
Drug: Spironolactone (an aldosterone antagonist) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) |
Resource links provided by NLM:
Further study details as provided by New England Research Institutes:
Primary Outcome Measures:
- Time to a composite outcome of cardiovascular mortality, aborted cardiac arrest, or hospitalization for the management of heart failure, whichever occurs first. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to cardiovascular mortality. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to aborted cardiac arrest. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to first hospitalization for the management of heart failure. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to all cause mortality. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Time to composite of cardiovascular mortality or cardiovascular related hospitalization (i.e., hospitalization for non-fatal MI, non-fatal stroke, or the management of heart failure). [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Hospitalization for the management of heart failure incidence rate. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to sudden death or aborted cardiac arrest. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to new onset diabetes mellitus, in subjects without a history of diabetes mellitus at baseline. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to development of atrial fibrillation, in subjects without a history of atrial fibrillation at baseline. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to myocardial infarction. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to stroke. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to deterioration of renal function. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Time to a composite outcome of sudden death, aborted cardiac arrest, or hospitalization for the management of ventricular tachycardia. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
- Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire. [ Time Frame: Baseline, Month 4, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
- Quality of life, as measured by the EuroQOL visual analog scale. [ Time Frame: Baseline, Month 4, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
- Quality of life, as measured by McMaster Overall Treatment Evaluation questionnaire. [ Time Frame: Month 4 and Month 12. ] [ Designated as safety issue: No ]
- Depression symptoms, as measured by Patient Health Questionnaire. [ Time Frame: Baseline, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
- Time to hospitalization for any reason. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Potassium [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Sodium [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Creatinine [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Chloride [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Bicarbonate [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
- Serum Blood Urea Nitrogen (BUN) [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
| Enrollment: | 3445 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo of spironolactone
|
|
Experimental: 2
Spironolactone
|
Drug: Spironolactone (an aldosterone antagonist)
Spironolactone is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
|
Detailed Description:
BACKGROUND:
Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.
Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.
As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.
DESIGN NARRATIVE:
This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
-
Heart failure as defined by at least one of the following symptoms at the time of screening and at least one of the following signs within 12 months prior to study entry:
-
SYMPTOMS:
- Paroxysmal nocturnal dyspnea
- Orthopnea
- Dyspnea on mild or moderate exertion
-
SIGNS:
- Any rales post cough
- Jugular venous pressure(JVP) greater than or equal to 10 cm H2O
- Lower extremity edema
- Chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly
-
- Left ventricular ejection fraction (ideally obtained by echocardiography, although radionuclide ventriculography and angiography are acceptable) greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction
- Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP
- Serum potassium less than 5.0 mmol/L prior to randomization
- At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry (transient heart failure in the context of MI does not qualify) OR brain natriuretic peptide (BNP) greater than or equal to 100 pg/ml or N-terminal pro-BNP greater than or equal to 360 pg/ml (not explained by another disease entity) within the 60 days prior to study entry
- Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation
- Willing to comply with scheduled visits
- Informed consent form signed by the subject prior to participation in the trial
EXCLUSION CRITERIA:
- Severe systemic illness with an expected life expectancy of less than 3 years
- Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
- Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
- Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
- Atrial fibrillation with a resting heart rate greater than 90 bpm
- MI in the past 90 days
- Coronary artery bypass graft surgery in the past 90 days
- Percutaneous coronary intervention in the past 30 days
- Heart transplant recipient
- Currently implanted left ventricular assist device
- Stroke in past 90 days
- Systolic BP (SBP) greater than 160 mm Hg
- Known orthostatic hypotension
- Gastrointestinal disorder that could interfere with study drug absorption
- Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;
- Known intolerance to aldosterone antagonists
- Current lithium use
- Current participation (including prior 30 days) in any other therapeutic trial
- Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
- History of hyperkalemia (serum potassium greater than or equal to 5.5 mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0 mmol/L within the past 2 weeks
- Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30 ml/min (per the Modification of Diet in Renal Disease (MDRD) 4-component study equation). Participants with serum creatinine greater than or equal to 2.5 mg/dl are also excluded even if their GFR is greater than or equal to 30 ml/min
- Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094302
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00094302
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Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Cardiovascular Consultants, Ltd. | |
| Glendale, Arizona, United States, 85306 | |
| Carl T. Hayden VA Medical Center | |
| Phoenix, Arizona, United States, 85012 | |
| United States, Arkansas | |
| Central Arkansas Veterans Healthcare System | |
| Little Rock, Arkansas, United States, 72205 | |
| Heart Clinic Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Cynthia Thaik | |
| Burbank, California, United States, 91505 | |
| Fresno VA Medical Center | |
| Fresno, California, United States, 93703 | |
| VA Medical Center West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Clinica Medica San Miguel | |
| Los Angeles, California, United States, 90015 | |
| CAPRI | |
| Los Angeles, California, United States, 90048 | |
| Mehrdad Kevin Ariani, MD, Inc. | |
| Northridge, California, United States, 91325 | |
| UC Davis Medical Center | |
| Sacremento, California, United States, 95829 | |
| Central Coast Cardiology | |
| Salinas, California, United States, 93901 | |
| Naval Medical Center San Diego | |
| San Diego, California, United States, 92134 | |
| Olive View - UCLA Medial Center | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| Cardio-Vascular Institute | |
| Greeley, Colorado, United States, 80631 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| Washington DC VA Hospital | |
| Washington, District of Columbia, United States, 20422 | |
| Howard University Hospital | |
| Washington DC, District of Columbia, United States, 20060` | |
| United States, Florida | |
| Daytona Heart Group | |
| Daytona Beach, Florida, United States, 32114 | |
| M & O Clinical Research, LLC | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Florida Heart Center | |
| Ft. Pierce, Florida, United States, 34950 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Mayo Clinic Florida | |
| Jacksonville, Florida, United States, 32224 | |
| Brevard Cardiovascular Research Associates, Inc | |
| Rockledge, Florida, United States, 37955 | |
| Tallahassee Research Institute | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Emory University at Grady Health System | |
| Atlanta, Georgia, United States, 30303 | |
| Morehouse School of Medicine | |
| Atlanta, Georgia, United States, 30310 | |
| Northside Cardiology Center | |
| Atlanta, Georgia, United States, 30342 | |
| InnovaMed Alliance | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60657 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Illinois at Chicago Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Cardiovascular Research Foundation | |
| Elk Grove Village, Illinois, United States, 60007 | |
| HeartCare Midwest | |
| Peoria, Illinois, United States, 61614 | |
| Heart, Lung and Vascular Institute | |
| Peoria, Illinois, United States, 61606 | |
| United States, Indiana | |
| The Care Group, LLC | |
| Indianapolis, Indiana, United States, 46260 | |
| Cardiovascular Research of Northwest Indiana, LLC | |
| Munster, Indiana, United States, 46321 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Baptist Healthcare System, Inc. d/b/a Baptist Hospital East | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Louisiana | |
| Leonard J. Chabert Medical Center | |
| Houma, Louisiana, United States, 70363 | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Northeast Cardiology | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Kaiser Permanente | |
| Largo, Maryland, United States, 20774 | |
| Northwest Hospital | |
| Randallstown, Maryland, United States, 21133 | |
| Delmarva Heart Research Foundation | |
| Salisbury, Maryland, United States, 21804 | |
| Associates in Cardiology, PA | |
| Silver Spring, Maryland, United States, 20910 | |
| United States, Massachusetts | |
| Caritas St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States, 02135 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Boston University Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Merrimack Valley Cardiology Associates | |
| Chelmsford, Massachusetts, United States, 01824 | |
| Compass Medical East Bridgewater | |
| East Bridgewater, Massachusetts, United States, 02333 | |
| Pentucket Medical Associates | |
| Haverhill, Massachusetts, United States, 01830 | |
| Charles River Medical Associates | |
| Natick, Massachusetts, United States, 01760 | |
| Hawthorn Medical Associates | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Umass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Veterans Affairs Ann Arbor Health Care System | |
| Ann Arbor, Michigan, United States, 48105 | |
| Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123 | |
| Detroit VA Medical Center | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Health Center | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Minneapolis VA Medical Center | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Heartland Regional Medical Clinic | |
| St. Joseph, Missouri, United States, 64506 | |
| United States, Montana | |
| Glacier View Cardiology | |
| Kalispell, Montana, United States, 59901 | |
| United States, Nebraska | |
| Bryan LGH Heart Institute | |
| Lincoln, Nebraska, United States, 68506 | |
| The Creighton Cardiac Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Deborah Heart and Lung Center | |
| Browns Mills, New Jersey, United States, 08015 | |
| Cardiovascular Associates of the Delaware Valley | |
| Elmer, New Jersey, United States, 08318 | |
| Cardiovascular Associates of the Delaware Valley | |
| Haddon Heights, New Jersey, United States, 08035 | |
| NJ Heart | |
| Linden, New Jersey, United States, 07036 | |
| St. Joseph's Regional Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| The Valley Hospital | |
| Ridgewood, New Jersey, United States, 07450 | |
| Electrophysiology Research Foundation | |
| Somerset, New Jersey, United States, 08873 | |
| Community Medical Center | |
| Toms River, New Jersey, United States, 08755 | |
| New Jersey Cardiology Associates | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| Bronx-Lebanon Hospital Center | |
| Bronx, New York, United States, 10457 | |
| New York Methodist Hospital | |
| Brooklyn, New York, United States, 11215 | |
| Research Foundation State University of New York at Buffalo | |
| Buffalo, New York, United States, 14203 | |
| Buffalo Heart Group, LLC | |
| Buffalo, New York, United States, 14215 | |
| Jamaica Hospital Medical Center | |
| Jamaica, New York, United States, 11418 | |
| Mid Valley Cardiology | |
| Kingston, New York, United States, 12401 | |
| Winthrop Cardiology Associates | |
| Mineola, New York, United States, 11501 | |
| Soundshore Medical Center of Westchester | |
| New Rochelle, New York, United States, 10802 | |
| NYU School of Medicine | |
| New York, New York, United States, 10016 | |
| St. Lukes Roosevelt | |
| New York, New York, United States, 10019 | |
| Northport VA Medical Center | |
| Northport, New York, United States, 11768 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14618 | |
| Lewin, Fagen, and Lown, MD, PC | |
| Smithtown, New York, United States, 11787 | |
| SUNY Upstate Medical Center | |
| Syracuse, New York, United States, 13210 | |
| Syracuse VA Medical Center | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Northeast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| Durham VA Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Lindner Clinical Trial Center | |
| Cincinnati, Ohio, United States, 45219 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| University Hospitals of Cleveland/Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State University Hospital East | |
| Columbus, Ohio, United States, 43205 | |
| VAMC Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCHS Clinical Research Office/Marymount Hospital | |
| Garfield Heights, Ohio, United States, 44125 | |
| CCHS Clinical Research Office/ Hillcrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| United States, Oklahoma | |
| Oklahoma City VA Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| COR Clinical Research | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Oklahoma Foundation for Cardiovascular Research | |
| Oklahoma City, Oklahoma, United States, 73210 | |
| Oklahoma Heart Institute | |
| Tulsa, Oklahoma, United States, 74137 | |
| United States, Oregon | |
| St. Charles Health System | |
| Bend, Oregon, United States, 97701 | |
| Providence Heart and Vascular Institute | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Capital Area Research | |
| Camp Hill, Pennsylvania, United States, 17011 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Medicor Associates, Inc | |
| Erie, Pennsylvania, United States, 16507 | |
| The Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Lancaster Heart and Stroke Foundation | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Eastwick Primary Care | |
| Philadelphia, Pennsylvania, United States, 19153 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Thomas Jefferson University Hospital- Dept. of Family and Community Health | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh VA Healthcare System | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| The Reading Hospital and Medical Center | |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, Rhode Island | |
| Memorial Hospital Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| VAMC - Charleston, SC | |
| Charleston, South Carolina, United States, 29401 | |
| United States, South Dakota | |
| Black Hills VA Health Care System | |
| Ft. Meade, South Dakota, United States, 57741 | |
| United States, Tennessee | |
| The Stern Cardiovascular Center | |
| Germantown, Tennessee, United States, 38138 | |
| Memphis Heart Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| Memphis VA Medical Center | |
| Memphis, Tennessee, United States, 38104 | |
| University of Tennessee Health Science Center | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Heart and Vascular Institute | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| DCT - APHC, LLC dba Discovery Clinical Trials | |
| Arlington, Texas, United States, 76014 | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| Cardiovascular Research Institute of Dallas | |
| Dallas, Texas, United States, 75231 | |
| U.T. Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Michael E. DeBakey VA Medical Cntr. | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital Research Institute | |
| Houston, Texas, United States, 77030 | |
| Wilford Hall Medical Center | |
| Lackland, Texas, United States, 78236 | |
| Texas Tech University Health Sciences Center | |
| Odessa, Texas, United States, 79763 | |
| Cardiology Clinic of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Tyler Cardiovascular Consultants | |
| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| LDS Hospital | |
| Murray, Utah, United States, 84157 | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Cardiovascular Associates Ltd. | |
| Chesapeake, Virginia, United States, 23320 | |
| Sentara Cardiovascular Research Institute | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Evergreen Healthcare | |
| Kirkland, Washington, United States, 98034 | |
| Providence St. Peter Hospital | |
| Olympia, Washington, United States, 98506 | |
| Sound Health Research | |
| Port Orchard, Washington, United States, 98366 | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| United States, West Virginia | |
| CAMC Health Education and Research Institute | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| University of Wisconsin-Madison | |
| Madison, Wisconsin, United States, 53792 | |
| William S. Middleton Memorial VA Hospital | |
| Madison, Wisconsin, United States, 53705 | |
| Aspirus Heart and Vascular Institute | |
| Wausau, Wisconsin, United States, 54401 | |
| Argentina | |
| Instituto de Investigaciones Clinicas de Bahia Blanca | |
| Bahia Blanca, Buenos Aires, Argentina, B80001JH | |
| Clinica Coronel Suarez | |
| Coronel Suarez, Buenos Aires, Argentina, b7540ghd | |
| Hospital Italiano de La Plata | |
| La Plata, Buenos Aires, Argentina, B1900 AXI | |
| Instituto de Investigaciones Clinicas de Mar Del Plata | |
| Mar del Plata, Buenos Aires, Argentina, B7600 FZN | |
| Instituto de Investigaciones Clinicas de Quilmes | |
| Quilmes, Buenos Aires, Argentina, 1878 | |
| Policlinico Modelo de Cipoletti | |
| Cipolletti, Rio Negro, Argentina, 8324 | |
| CIPREC | |
| Buenos Aires, Argentina, C1119ACN | |
| Clinica IMA | |
| Buenos Aires, Argentina, J846 | |
| IMAI Research | |
| Buenos Aires, Argentina, 1425 | |
| Instituto Cardiologico Ezpecializado S.R.L | |
| Buenos Aires, Argentina, C1426 ANZ | |
| Clinica Privada Del Prado | |
| Cordoba, Argentina, X500AAW | |
| Instituto de Investigaciones Clinicas de Rosario | |
| Rosario Santa Fe, Argentina, 2000 | |
| Hospital San Bernardo | |
| Salta, Argentina, A4406CLA | |
| Centro de Investigaciones Clinicas del Litoral SRL | |
| Santa Fe, Argentina, 3000 | |
| Sanatorio Mayo S.A. | |
| Santa Fe, Argentina | |
| Centro Modelo de Cardiología | |
| Tucuman, Argentina | |
| Centro Privado de Cardiologia | |
| Tucuman, Argentina, T4000NIL | |
| Instituto de Cardiologia SRL | |
| Tucuman, Argentina | |
| Brazil | |
| Hospital Felicio Rocho | |
| Belo Horizonte, Brazil | |
| Santa Casa De Belo Horizonte | |
| Belo Horizonte, Brazil | |
| HMCP PUC Campinas | |
| Campinas, Brazil | |
| Irmandade da Santa Casa de Misericordia de Curitiba | |
| Curitiba Parana, Brazil | |
| Hospital das Clinicas da Universidade Federal de Goias | |
| Goias, Brazil | |
| Instituto do Coracao de Marilia | |
| Marilia Sao Paulo, Brazil | |
| Hospital Sao Vicente de Paulo | |
| Passo Fundo, Brazil | |
| PROCAPE | |
| Pernambuco, Brazil | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Brazil, 90035-903 | |
| Hospital Mae De Deus | |
| Porto Alegre, Brazil | |
| Hospital Universitario Pedro Ernesto | |
| Rio de Janeiro, Brazil | |
| Santa Casa de Misericordia do Rio de Janeiro | |
| Rio de Janeiro, Brazil | |
| Instituto de Molestias Cardiosvaculares | |
| San Paulo, Brazil | |
| Instituto de Cardiologia de Santa Catarina | |
| Santa Catarina, Brazil | |
| UNIFESP/Hospital Sao Paulo | |
| Sao Paulo, Brazil | |
| Incor Fmusp | |
| Sao Paulo, Brazil | |
| Instituto do Coracao do Triangulo Mineiro | |
| Uberlandia, Brazil | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Canada, British Columbia | |
| Fraser Clinical Trials Inc. | |
| New Westminster, British Columbia, Canada, V3L 3W4 | |
| Canada, Manitoba | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H2A6 | |
| Canada, Newfoundland and Labrador | |
| Health Science Centre | |
| St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Dr. Saul Vizel Cardiac Research Office | |
| Cambridge, Ontario, Canada, N1R 7R1 | |
| Cornwall Clinical Trials | |
| Cornwall, Ontario, Canada, K6H 4M4 | |
| Hamilton Health Sciences - General Site | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| London Health Sciences Center | |
| London, Ontario, Canada, N6A 5A5 | |
| Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Dr. Gurcharan Syan (PP) | |
| Sudbury, Ontario, Canada, P3C 5K7 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G1X5 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Canada, Quebec | |
| CHUS - Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Service de la Recherche | |
| Granby, Quebec, Canada, J2G 1T7 | |
| Cite de la Sante de Laval | |
| Laval, Quebec, Canada, H7M 3L9 | |
| Clinique Cardiologie Levis | |
| Levis, Quebec, Canada, G6V 4Z5 | |
| Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| CHUM - Hotel Dieu | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Chum Hotel Dieu | |
| Montreal, Quebec, Canada, H2W IT8 | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G IA4 | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Hopital Du Sacre Coeur de Montreal | |
| Montreal, Quebec, Canada, A4J 1C5 | |
| Centre de recherche clinique de Quebec | |
| Quebec City, Quebec, Canada, G1J 1Z6 | |
| Centre Hosp Regional de Lanaudiere | |
| Sainte Charles Borromee, Quebec, Canada, J6E 6J2 | |
| C.S.S.S.B. | |
| St. George, Quebec, Canada, G5Y 4T8 | |
| Hopital Laval | |
| Ste-Foy, Quebec, Canada, GIV 4G5 | |
| CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur) | |
| Terrebonne, Quebec, Canada, J6V 2H2 | |
| Centre De Sante et De Services Sociaux De Thetford | |
| Thetford-Mines, Quebec, Canada, G6G 2V4 | |
| Canada | |
| Misericordia Hospital - Cardiac Sciences | |
| Edmonton, Canada | |
| CDRC Rive-Sud | |
| Longueuil, Canada | |
| SMBD Jewish General Hospital | |
| Montreal, Canada | |
| Saskatchewan Heart Centre | |
| Saskatoon, Canada | |
| Cardiology Clinical Trials - Surrey Memorial Hospital | |
| Surrey, Canada | |
| Centre Hospitalier de Trois-Rivieres | |
| Trois Rivieres, Canada | |
| Georgia | |
| L &J Clinic | |
| Kutaisi, Georgia, 4600 | |
| Tbilisi State Medical University Clinic #1 | |
| Tbilisi, Georgia, 0102 | |
| Clinic of Angiocardiology "ADAPTI" | |
| Tbilisi, Georgia, 0186 | |
| Diagnostic Services Clinic | |
| Tbilisi, Georgia, 0179 | |
| Emergency Cardiology Centre | |
| Tbilisi, Georgia, 0159 | |
| Multiprofile Clinical Hospital of Tbilisi #2 | |
| Tbilisi, Georgia, 0154 | |
| National Center of Therapy | |
| Tbilisi, Georgia, 0159 | |
| Cardio-Reanimation Centre | |
| Tbilisi, Georgia, 0141 | |
| Cardiology Clinic | |
| Tibilisi, Georgia, 0144 | |
| Russian Federation | |
| Municipal Healthcare Institution <> | |
| Gatchina, Leningrad Region, Russian Federation, 188300 | |
| Municipal Health Care Institution "City Hospital #1" | |
| Barnaul, Russian Federation, 656099 | |
| Altay State Medical University of federal agency of public health and social progress RF | |
| Barnaul, Russian Federation, 656038 | |
| Kaliningrad Region Hospital | |
| Kaliningrad, Russian Federation, 236016 | |
| Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy | |
| Kemerovo, Russian Federation, 650002 | |
| Nonstate Healthcare Institution | |
| Kemerovo, Russian Federation, 650036 | |
| State Healthcare Institution "Region Clinical Hospital #1 | |
| Krasnodar, Russian Federation, 350086 | |
| Federal State Institution "Outpatient clinic #3 of President's Management Department of Russian Fede | |
| Moscow, Russian Federation, 129090 | |
| National Research Center for Preventitive Medicine | |
| Moscow, Russian Federation, 101990 | |
| Non State Health Care Institution Central Hospital #6 of Russian Railways JSC | |
| Moscow, Russian Federation | |
| Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory | |
| Moscow, Russian Federation, 777020 | |
| Russian State Medical University, Hospital Therapy Department #1 | |
| Moscow, Russian Federation, 111539 | |
| State Education High Professional Education Russian State Medical University | |
| Moscow, Russian Federation, 115093 | |
| Novosibirsk Municipal Clinical Emergency Hosp. # 2 | |
| Novosibirsk, Russian Federation, 630008 | |
| Chair of Nephrology and Dialysis of St Petersburg State Medical University | |
| Saint Petersburg, Russian Federation | |
| Saint-Petersburg State Healthcare Institution "City Alexander's Hospital" | |
| Saint Petersburg, Russian Federation, 193312 | |
| Saint-Petersburg State Institution of Health Protection, "City Hosptial # 15" | |
| Saint Petersburg, Russian Federation, 198205 | |
| Medico- Military Academy, Navy Therapy Dept | |
| Saint-Petersburg, Russian Federation, 198013 | |
| Public Institution of Health City Hospital # 28 | |
| Saint-Petersburg, Russian Federation, 190000 | |
| Saint-Petersburg State Health Institution "Pokrovskaya City Hospital" | |
| Saint-Petersburg, Russian Federation, 199106 | |
| Federal State Health Care Institution | |
| Saint-Petersburg, Russian Federation, 194291 | |
| Federal State Institution | |
| Saratov, Russian Federation, 410028 | |
| State Educational Institution of High Professional Education Saratov State Medical University | |
| Saratov, Russian Federation, 410054 | |
| Almasov research institute of Cardiology | |
| St. Petersberg, Russian Federation, 194156 | |
| City Hospital No 26 | |
| St. Petersburg, Russian Federation, 196247 | |
| City Hospital #26 | |
| St. Petersburg, Russian Federation, 196247 | |
| State Institution Saint-Petersburg Dzhanelidze Scientific | |
| St. Petersburg, Russian Federation, 192242 | |
| Non-state Health Care Institution | |
| St. Petersburg, Russian Federation, 195221 | |
| Saint-Petersburg Clinical Hospital of RAMS, policlinic department | |
| St. Petersburg, Russian Federation, 194017 | |
| Chair and Department of Hospital Therapy | |
| St. Petersburg, Russian Federation, 197089 | |
| Saint-Petersburg State Health Care Institution "City Hospital of Saint George the Martyr" | |
| St. Petersburg, Russian Federation, 194354 | |
| State Institition Research Institution of Cardiology of Tomsk | |
| Tomsk, Russian Federation, 634012 | |
| State Educational institution of Higher Professional Education "Volgograd State Medical University o | |
| Volgograd, Russian Federation, 400001 | |
| State Health Care Institution "Voronezh Regional Clinical Consultative & Diagnostic Centre" | |
| Voronezh, Russian Federation, 396018 | |
| City Healthcare Institution Clinical Hospital #8 | |
| Yaroslavl, Russian Federation, 150030 | |
| Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, Russian Federation, 150068 | |
Sponsors and Collaborators
New England Research Institutes
Investigators
| Principal Investigator: | Sonja M. McKinlay, PhD | New England Research Institutes, Inc. |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT00094302 History of Changes |
| Other Study ID Numbers: | 160, HHSN268200425207C |
| Study First Received: | October 15, 2004 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New England Research Institutes:
|
Heart Failure Diastolic Heart Failure Preserved Ejection Fraction |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Failure Heart Diseases Mineralocorticoid Receptor Antagonists Spironolactone Cardiovascular Agents Diuretics |
Diuretics, Potassium Sparing Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015