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NCT02606253 · ClinicalTrials.gov registry record · Phase 4
Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure
A Phase 4 study of Heart Failure, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02606253: Completed Phase 4 study of Heart Failure, sponsored by Vanderbilt University.
NCT02606253 is a Phase 4 study of Heart Failure that has completed, run by Vanderbilt University. The registered enrollment target is 60 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02606253, a Phase 4 study of Heart Failure, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Broad Objectives: To determine the comparative efficacy of commonly employed strategies to overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized decompensated heart failure patients with hypervolemia Specific Aims: 1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in decompensated heart failure 2. Compare the adverse effects of electrolyte depletion and renal function changes between intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure 3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure The investigators will conduct a dual center, randomized, double-blind, double-dummy, parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic decompensated heart failure and displaying loop diuretic resistance.
Primary Outcome
The primary outcome will be 48-hour standing scale weight change (kg) from enrollment among the metolazone, intravenous chlorothiazide, and tolvaptan arms, using metolazone group as the comparator group for all other groups.
Conditions Studied
Interventions
- DRUG Metolazone
- DRUG tolvaptan
- DRUG Chlorothiazide
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 4 |
What the finished NCT02606253 record still lists
NCT02606253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which Metolazone is the first listed.
NCT02606253 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02606253 about?
NCT02606253 is a clinical study titled "Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure". Broad Objectives: To determine the comparative efficacy of commonly employed strategies to overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized decompensated heart failure patients with hypervolemia Specific Aims: 1. Compare the 48-hour weight change of either...
What is the current status of trial NCT02606253?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2016-02. Estimated completion is 2018-10-31.
What conditions does trial NCT02606253 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT02606253?
The interventions under investigation include: Metolazone (DRUG), tolvaptan (DRUG), Chlorothiazide (DRUG).
Who is sponsoring clinical trial NCT02606253?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02606253 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02606253's enrollment target sits among peer trials
60 254th of 397 higher than 131 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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