CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 360 enrolled
Drug / intervention
Spironolactone +1 moredrug
Likely dose
Spironolactone 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02235077
NCT02235077Phase 2Completed
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Aldosterone Targeted Neurohormonal Combined With Natriuresis Therapy - HF (ATHENA-HF)

Duke University·interventional·Posted Sep 9, 2014·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Spironolactone and Placebo for Heart Failure. Completed, enrolled 360 participants across 22 sites.

Detailed Summary

The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartDec 30, 2014
Primary CompletionApr 12, 2016
Study CompletionJun 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

Interventions

Spironolactonedrug

Patients receiving no MRA at home will receive spironolactone 100 mg (4x25 mg capsules) once daily for 96 hours. Patients already receiving low-dose MRA at home will be randomized to receive spironolactone 25 mg (1x25 mg capsules) or 100 mg (4x25 mg capsules) in hospital for 96 hours. The patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding.

Placebodrug

Patients receiving no MRA at home will receive 100 mg placebo (4x25 mg capsules) once daily for 96 hours. Patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding.