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NCT02585843 · ClinicalTrials.gov registry record · Phase 2
Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02585843 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 20 participants.
The verdict
NCT02585843, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a prospective, single-center, double-blind and randomized placebo controlled trial for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of signs and symptoms of congestion in outpatients with acute decompensated heart failure (ADHF). Patients who are not responding to their current loop diuretics will be considered for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care in management of heart failure (HF) patients. However, recommended doses of MRAs (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of this outpatient regimen to improve diuresis and possible reduction in hospitalization for further diuretic management in HF patients with signs and symptoms of congestion.
Interventions
- DRUG Spironolactone 25mg
- DRUG Spironolactone 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02585843
The ClinicalTrials.gov registry entry for NCT02585843 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Spironolactone 25mg is the first listed.
NCT02585843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02585843 about?
NCT02585843 is a clinical study titled "Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance". This is a prospective, single-center, double-blind and randomized placebo controlled trial for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of signs and symptoms of congestion in outpatients with acute decompensated heart failure (ADHF). Patients who are not...
What is the current status of trial NCT02585843?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-11. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02585843?
The interventions under investigation include: Spironolactone 25mg (DRUG), Spironolactone 100mg (DRUG).
Who is sponsoring clinical trial NCT02585843?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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