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Phase 4 N=52 Randomized Quadruple-blind Treatment

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

Heart Failure

Enrolled (actual)
52
Serious AEs
7.7%
Results posted
Mar 2017
Primary outcome: Primary: Exercise Treadmill Time — 621; 580; 624; 579 seconds — p=0.90

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
aliskiren (Drug); placebo (Drug)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Sep 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Exercise Treadmill Time
621; 580; 624; 579; 607; 605 0.90

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).

Eligibility 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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00982033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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