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Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00585611
Recruitment Status : Terminated (Unable to recruit into the study)
First Posted : January 3, 2008
Last Update Posted : October 5, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.

Condition or disease Intervention/treatment
Diastolic Heart Failure Drug: Atorvastatin Other: placebo

Detailed Description:
Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
Study Start Date : December 2005
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Atorvastatin
Heart failure patients assigned to atorvastatin
Drug: Atorvastatin
Atorvastatin - 40 mg orally daily for 6 months
Placebo Comparator: 2 Drug: Atorvastatin
Atorvastatin - 40 mg orally daily for 6 months
Other: placebo

Outcome Measures

Primary Outcome Measures :
  1. Change in carotid-femoral pulse wave velocity (CFPWV) in the statin treated vs. control group [ Time Frame: 6 months after initiation of intervention ]

Secondary Outcome Measures :
  1. Composite cardiovascular endpoint incorporating quality of life (QOL) assessment + hospitalizations for cardiovascular disease and mortality [ Time Frame: 6 months after initiation of intervention ]
  2. Changes in submaximal exercise capacity measured by 6-minute walk test [ Time Frame: 6 months after initiation of intervention ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent,
  • Age > 18,
  • Ejection fraction ≥ 50%,
  • hospitalization for heart failure in the last 6 months and
  • current NYHA Class II-IV symptoms, OR
  • current NYHA Class III-IV symptoms and one of the following:

    1. ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy,
    2. chest x-ray evidence of pulmonary congestion

Exclusion Criteria:

  • Probable alternative cause of symptoms (pulmonary disease, severe anemia, etc.)
  • Prior documented LVEF < 40% or qualitative moderate or greater LV systolic dysfunction.
  • Current indication for statin therapy
  • Intolerance to statin therapy.
  • Documented ischemic heart disease requiring lipid-lowering therapy (i.e. CAD, myocardial infarction, stroke)
  • Evidence of significant myocardial ischemia on stress testing at screening visit.
  • Evidence of hepatic abnormality (defined as liver enzymes > 2 times the upper limit of normal values).
  • Uncontrolled hypertension (BP > 150/100)
  • Significant valvular disease.
  • Atrial fibrillation
  • Known familial hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy.
  • Restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease (i.e. amyloidosis, sarcoidosis, hemochromatosis).
  • Cor pulmonale or other cause of right heart failure not related to LV dysfunction.
  • Clinically significant pulmonary disease.
  • Pericardial constriction or hemodynamically significant pleural effusion.
  • Uncontrolled arrhythmia.
  • Any systemic condition other than heart failure that may limit survival to less than 2 years.
  • Advance renal disease (serum creatinine > 3.0 mg/dl or on dialysis)
  • Known intolerance or allergy to HMG CoA reductase inhibitors
  • Uncontrolled hyper- or hypothyroidism.
  • Any subject characteristic that may interfere with study compliance, such as baseline dementia, substance abuse, history of non-compliance with medications or appointments.
  • Prisoners or other vulnerable populations.
  • Any woman of child-bearing age with a documented positive pregnancy test.
  • Subject is receiving therapy with other investigational therapy or is participating in any other clinical trial.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585611

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Nancy K Sweitzer, MD PhD University of Wisconsin, Madison
More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585611     History of Changes
Other Study ID Numbers: HSC# 2005-430
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: May 2011

Keywords provided by University of Wisconsin, Madison:
Heart Failure, Congestive

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors