Low-Dose Colchicine for Heart Failure with Preserved Ejection Fraction and Inflammation
This study is looking at whether low-dose colchicine (LoDoCo) can improve exercise ability in people with a type of heart failure called HFpEF (heart failure with preserved ejection fraction) and inflammation. LoDoCo is being tested to see if it helps with exercise capacity, physical function, and quality of life. To join, you must be 50 or older and have a specific inflammation marker (hs-CRP) of 2 mg/L or higher. The main goal is to see if LoDoCo improves your peak VO2 (a measure of how well your body uses oxygen during exercise) after 3 months. This is an investigational use of LoDoCo, meaning the FDA has not yet approved it for this specific condition. The study is currently recruiting 60 participants.
- Study design
- This is a single-center, double-blind (neither you nor your doctor will know if you're getting the drug or placebo) pilot study comparing low-dose colchicine to a placebo. It plans to enroll 60 participants.
- What's involved
- You will have a 1-day screening that includes a blood draw and physical exam. Outcomes will be assessed at the beginning of the study and again after 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after starting the intervention.
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Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ambarish Pandey, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Peak VO2 indexed to body weightOver 3 months
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 population mean VO2peak of 10.5 ml/kg/min (SD 2.9) based on data from our local registry. Assuming a dropout rate of \~20%, we will plan to enroll 72 participants. We will also evaluate the association between changes in hs-CRP with changes in VO2peak across the entire cohort of participants using adjusted linear and logistic regression models