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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aliskiren
placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure with normal ejection fraction, Elderly

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aliskiren

Placebo

Arm Description

50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.

50% of subjects will be randomized to placebo.

Outcomes

Primary Outcome Measures

Exercise Treadmill Time
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2009
Last Updated
February 12, 2019
Sponsor
Wake Forest University Health Sciences
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00982033
Brief Title
Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction
Acronym
Aliskiren
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure with normal ejection fraction, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren
Arm Type
Active Comparator
Arm Description
50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50% of subjects will be randomized to placebo.
Intervention Type
Drug
Intervention Name(s)
aliskiren
Other Intervention Name(s)
Tekturna
Intervention Description
aliskiren 300mg qd versus placebo for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo qd for 24 weeks
Primary Outcome Measure Information:
Title
Exercise Treadmill Time
Description
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.
Time Frame
Baseline, 24 week visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalane W Kitzman, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22981266
Citation
Scott JM, Haykowsky MJ, Eggebeen J, Morgan TM, Brubaker PH, Kitzman DW. Reliability of peak exercise testing in patients with heart failure with preserved ejection fraction. Am J Cardiol. 2012 Dec 15;110(12):1809-13. doi: 10.1016/j.amjcard.2012.08.015. Epub 2012 Sep 13.
Results Reference
result
PubMed Identifier
29910050
Citation
Upadhya B, Brubaker PH, Morgan TM, Eggebeen JD, Jao GT, Stewart KP, Kitzman DW. The effect of Aliskiren on exercise capacity in older patients with heart failure and preserved ejection fraction: A randomized, placebo-controlled, double-blind trial. Am Heart J. 2018 Jul;201:164-167. doi: 10.1016/j.ahj.2018.03.019. Epub 2018 Apr 4.
Results Reference
derived

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

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