deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00108251

Aldosterone Antagonism in Diastolic Heart Failure

Sponsor: US Department of Veterans Affairs

Updated 6 times since 2017 Last updated: Sep 7, 2011 Started: Aug 31, 2004 Primary completion: Sep 30, 2007 Completion: Oct 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00108251, this PHASE4 trial focuses on Congestive Heart Failure and Diastole and remains completed. Sponsored by US Department of Veterans Affairs, it has been updated 6 times since 2004, reflecting limited change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

The objectives of this study are: 1) To evaluate the effect of eplerenone, an aldosterone antagonist, on intermediate functional outcomes in patients with DHF (diastolic heart failure); 2) To evaluate the effect of eplerenone, an aldosterone antagonist, on echocardiographic measures of diastolic dysfunction in patients with DHF. The study is an double-blind, placebo-controlled study evaluating the effects of eplerenone compared to placebo in patients with DHF. A total of 48 patients with DHF will be randomized in a 1:1 ratio to 1) Placebo (n=24) or to 2) Eplerenone (n=24) in a dose of 25 mg a day for the first 2 weeks followed by uptitration to 50 mg a day for 22 weeks. The primary outcome is an improvement in functional capacity, measured by the distance covered in a 6-minute walk test. Secondary Outcomes include : Change echocardiographic measures of diastolic dysfunction, change in levels of B-type natriuretic peptide (BNP)and change in quality of life.

The objectives of this study are: 1) To evaluate the effect of eplerenone, an aldosterone antagonist, on intermediate functional outcomes in patients with DHF (diastolic heart failure); 2) To evaluate the effect of eplerenone, an aldosterone antagonist, on echocardiographic measures of diastolic dysfunction in patients with DHF.

The study is an double-blind, placebo-controlled study evaluating the effects of eplerenone compared to placebo in patients with DHF. A total of 48 patients with DHF will be randomized in a 1:1 ratio to 1) Placebo (n=24) or to 2) Eplerenone (n=24) in a dose of 25 mg a day for the first 2 weeks followed by uptitration to 50 mg a day for 22 weeks. The primary outcome is an improvement in functional capacity, measured by the distance covered in a 6-minute walk test. Secondary Outcomes include : Change echocardiographic measures of diastolic dysfunction, change in levels of B-type natriuretic peptide (BNP)and change in quality of life.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshotCompleted~Aug 2018 – ~Jan 2021 · 29 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Aug 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jun 2018 — Aug 2018 [monthly]

    Completed PHASE4

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Aug 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • US Department of Veterans Affairs
Data source: VA Office of Research and Development

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations