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

Completed · Phase 4 · Has a placebo group

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT00982033

Run by

Wake Forest University Health Sciences

People needed

52

Starts

2009-07-01

Expected to finish

2011-12-01

Last updated by the study team

2019-02-27

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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