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

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: placebo; Drug: aliskiren

• Registration Number: NCT00982033
• Lead Sponsor: Wake Forest University Health Sciences

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).

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Results First Submitted: 2016-10-31
• Results First Submitted QC: 2017-01-31
• Results First Posted: 2017-03-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	50% of subjects will be randomized to placebo.
Aliskiren	aliskiren	50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.

Primary Outcome Measures

Name	Time	Method
Exercise Treadmill Time	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States