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Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure

NCT02235077 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-06-14

Study results available
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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.

Conditions

Interventions

DRUG

Spironolactone

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Adrian Hernandez, MD · Duke University Health Systems

  • Eugene Braunwald, MD · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-30
Primary Completion
2016-04-12
Completion
2016-06-06

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02235077 on ClinicalTrials.gov