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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aliskiren

50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.

Group Type ACTIVE_COMPARATOR

aliskiren

Intervention Type DRUG

aliskiren 300mg qd versus placebo for 24 weeks.

Placebo

50% of subjects will be randomized to placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo qd for 24 weeks

Interventions

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aliskiren

aliskiren 300mg qd versus placebo for 24 weeks.

Intervention Type DRUG

placebo

placebo qd for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Tekturna

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No