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

Wake Forest University (WFU)

Status and phase

Completed

Phase 4

Conditions

Heart Failure

Treatments

Drug: aliskiren

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00982033

CTA study # CSPP100AUS13T

GTS # 34136

IRB00008625

Details and patient eligibility

About

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).

Full 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.

Enrollment

52 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.