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NCT06286423 · ClinicalTrials.gov registry record · Phase 4
Colchicine in Acutely Decompensated HFREF
A Phase 4 study of Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06286423 is a Phase 4 study of Heart Failure and Heart Failure With Reduced Ejection Fraction that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 30 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06286423, a Phase 4 study of Heart Failure and Heart Failure With Reduced Ejection Fraction, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo. Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol. These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo. Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpa
Conditions Studied
Interventions
- DRUG Colchicine 0.6 mg
- DRUG Control/Placebo group
Study Locations (1)
Virginia
- UVA Health - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-06 |
| Est. Completion | 2028-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06286423
The ClinicalTrials.gov registry entry for NCT06286423 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Colchicine 0.6 mg is the first listed.
NCT06286423 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT06286423 about?
NCT06286423 is a clinical study titled "Colchicine in Acutely Decompensated HFREF". This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo. Upon enrollment, patients will be randomized 1:1 to receive either the experimental...
What is the current status of trial NCT06286423?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2024-06. Estimated completion is 2028-06.
What conditions does trial NCT06286423 study?
This clinical trial studies the following conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, Decompensated Heart Failure.
What interventions are being tested in trial NCT06286423?
The interventions under investigation include: Colchicine 0.6 mg (DRUG), Control/Placebo group (DRUG).
Who is sponsoring clinical trial NCT06286423?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06286423 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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