NCT00982033

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 22, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

September 18, 2009

Results QC Date

October 31, 2016

Last Update Submit

February 12, 2019

Conditions

Heart Failure

Keywords

Heart failure with normal ejection fractionElderly

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 24 week visit

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

50% of subjects will be randomized to placebo.

Drug: placebo

Interventions

aliskirenDRUG

aliskiren 300mg qd versus placebo for 24 weeks.

Also known as: Tekturna
Aliskiren
placeboDRUG

placebo qd for 24 weeks

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

  • 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.

    PMID: 22981266RESULT

  • 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.

    PMID: 29910050DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dalane W. Kitzman, M.D.
Organization
Wake Forest School of Medicine
dkitzman@wakehealth.edu
336-716-3274

Study Officials

  • Dalane W Kitzman, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

February 27, 2019

Results First Posted

March 22, 2017

Record last verified: 2019-02

Locations

US(1)