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Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction (Aliskiren)

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: NCT00982033
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : March 22, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients with heart failure and normal ejection fraction (HFNEF).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: aliskiren Drug: placebo Phase 4

Detailed Description:
Heart Failure with Normal Ejection Fraction (HFNEF) is the most common form of heart failure, particularly in older persons. However, the optimal therapy for this disorder has not been defined. The primary chronic symptom in HFNEF is exercise intolerance, manifested by shortness of breath and fatigue with exercise. This is the major determinant of quality of life, can be measured objectively and reproducibly and is modifiable.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-Controlled Six Month Treatment Trial of Aliskiren to Improve Exercise Tolerance in Older Patients With Heart Failure and Normal Ejection Fraction
Study Start Date : July 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Aliskiren

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aliskiren
50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
 Drug: aliskiren
aliskiren 300mg qd versus placebo for 24 weeks.
Other Name: Tekturna
Placebo Comparator: Placebo
50% of subjects will be randomized to placebo.
 Drug: placebo
placebo qd for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Exercise Treadmill Time [ Time Frame: Baseline, 24 week visit ]

    Treadmill exercise time to exhaustion on the modified naughton protocol.

    LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model.



Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 55 years of age
  • Symptomatic HFNEF of at least 1 month duration.
  • Reduced early diastolic mitral annular velocity by tissue Doppler
  • Left ventricular ejection fraction (LVEF ≥ 0.50)
  • Baseline exercise intolerance
  • Patients who are able to provide written informed consent
  • Stable medical therapy for 30 days prior to screening

Exclusion Criteria:

  • Seated blood pressure ≥ 160/90 mmHg at Visit 1 (screening)
  • Clinically significant pulmonary disease
  • Known history of documented EF < 0.45 at any time
  • Clinically unstable heart failure, medication changes for worsening heart failure symptoms within the past 4 weeks
  • Severe anemia (Hgb <10 mg/dL)
  • Clinical evidence of uncontrolled hypo or hyperthyroidism
  • Clinically significant valvular heart disease
  • Surgical correction of valvular heart disease within the last year
  • Known familial hypertrophic cardiomyopathy or hypertrophic obstructive cardiomyopathy
  • Known restrictive cardiomyopathy or systemic illness known to be associated with infiltrative myocardial disease (e.g. amyloidosis, sarcoidosis, hemachromatosis)
  • Pericardial restriction or hemodynamically significant pericardial effusion
  • Cor pulmonal or other causes of right heart failure not related to LV dysfunction
  • Extreme obesity (weight > 325 pounds)
  • Acute coronary syndrome within past 3 months
  • Coronary artery revascularization within past 3 months
  • Peripheral artery revascularization within past 3 months
  • Acute cerebrovascular syndrome (stroke or TIA) within the past 3 months
  • Uncontrolled symptomatic brady- or tachyarrhythmia
  • Creatinine > 2.5 mg/dl at screening
  • Potassium > 5.2 meq/l at screening
  • Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren
  • Current treatment with antidepressant medication in the MAO(Monoamine Oxidase) inhibitor or SSRI(Selective serotonin reuptake inhibitors) class
  • Current participation in another clinical trial
  • Current treatment with both an ACE(Angiotensin-converting enzyme) inhibitor and an angiotensin receptor antagonist.
  • Known significant bilateral renal artery stenosis
  • Serious non-cardiovascular disease severely limiting life expectancy
  • Previous major organ (e.g., lung, liver, heart, kidney) transplantation or on a transplant waiting list
  • Any condition that is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no permanent home)
  • Pregnant women, nursing women, and women of childbearing potential.
Contacts and Locations
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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): NCT00982033


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Dalane W Kitzman, MD Wake Forest University Health Sciences
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00982033    
Other Study ID Numbers: IRB00008625
CTA study # CSPP100AUS13T
GTS # 34136
First Posted: September 22, 2009    Key Record Dates
Results First Posted: March 22, 2017
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Heart failure with normal ejection fraction
Elderly
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases