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NCT06130059 · ClinicalTrials.gov registry record · Phase 2
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
A Phase 2 study of Heart Failure and Inflammation, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06130059: Recruiting Phase 2 study of Heart Failure and Inflammation, sponsored by University of Texas Southwestern Medical Center.
NCT06130059 is a Phase 2 study of Heart Failure and Inflammation that is actively recruiting participants, run by University of Texas Southwestern Medical Center. 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
NCT06130059, a Phase 2 study of Heart Failure and Inflammation, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation. The use of LoDoCo in this study is considered investigational as it has not been approved by the Food and Drug Administration (FDA) for the treatment of exercise capacity in patients with HFpEF. Participants will undergo a 1-day screening that includes a blood draw and physical examination. If deemed eligible for the study, participants will undergo a baseline visit within 2 weeks of screening visit that includes physical examination, exercise testing, echocardiography and completion of quality-of-life surveys. Participants will also be randomized at this visit (randomly assigned to a group) to receive either LoDoCo or placebo (inactive substance) for 3 months. Participants will be called back at 3 months for repeat physical examination, blood draws, echocardiography, exercise testing and completion of quality-of-life surveys. Each visit will take about 3 hours. Total study duration is about 3 months.
Primary Outcome
The primary outcome of the trial will be VO2peak indexed to body weight. (mL/kg/min). The data will be analyzed on an intention-to-treat basis comparing the outcomes across treatment arms (LoDoCo vs. placebo) using analysis of variance for repeated measures (ANOVA). Randomization of 60 participants (30 in LoDoCo vs. placebo) will provide \>80% power at a two-sided level of significance of 0.05 to detect a \>15% difference in VO2peak at the end of the study period. This estimate assumes a target
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low Dose Colchicine
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06130059 shows while recruiting
NCT06130059 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 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06130059 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06130059 about?
NCT06130059 is a clinical study titled "Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation". The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation....
What is the current status of trial NCT06130059?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-04-24. Estimated completion is 2027-12-31.
What conditions does trial NCT06130059 study?
This clinical trial studies the following conditions: Heart Failure, Inflammation.
What interventions are being tested in trial NCT06130059?
The interventions under investigation include: Placebo (DRUG), Low Dose Colchicine (DRUG).
Who is sponsoring clinical trial NCT06130059?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06130059 being conducted?
This trial has 1 study location across Texas. 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 NCT06130059'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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