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

February 12, 2019 updated by: Wake Forest University Health Sciences

A Randomized, Blinded, Placebo-Controlled Six Month Treatment Trial of Aliskiren to Improve Exercise Tolerance in Older Patients With Heart Failure and Normal Ejection Fraction

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Aliskiren
50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
Drug: aliskiren
aliskiren 300mg qd versus placebo for 24 weeks.
Other Names:
  • Tekturna
PLACEBO_COMPARATOR: Placebo
50% of subjects will be randomized to placebo.
Drug: placebo
placebo qd for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Treadmill Time
Time Frame: 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.
Baseline, 24 week visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (ESTIMATE)

September 22, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008625
  • CTA study # CSPP100AUS13T
  • GTS # 34136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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