Heart Failure study: Low Dose Colchicine
Official title Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
ClinicalTrials.gov ID: NCT06130059
What this study is testing
What is Low Dose Colchicine (LoDoCo)?
An investigational oral medication being studied for improving exercise capacity and quality of life in patients with heart failure with preserved ejection fraction.
Also referred to as Colchicine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether colchicine can improve exercise capacity, physical function, frailty, and quality of life in patients with heart failure with preserved ejection fraction and systemic inflammation.
- Who it's for
- Adults with stable heart failure with preserved ejection fraction and evidence of inflammation.
- What's involved
- Participants will have a screening day with a blood draw and exam, then a baseline visit with exams, exercise tests, an echo, and surveys. They will be randomly given colchicine or a placebo for 3 months, then return for the same tests at 3 months.
- Time commitment
- The study lasts about 3 months and includes a 3‑hour screening day, a baseline visit, and a 3‑month follow‑up visit.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 1\. Informed consent was obtained before any study-related activities.
- a. Structural Heart Disease with one of the following on echocardiography within 12 months of enrolment.
- i. LA volume index \> 34 ml/m2. ii. LA diameter ≥ 3.8 cm. iii. LA length ≥ 5.0 cm. iv. LA area ≥ 20 cm2. v. LA volume ≥ 55 mL. vi.
You likely can't join if
- 1\. Do not otherwise meet the inclusion criteria. 2. Women who are pregnant, breastfeeding, or may be considering pregnancy during the study period.
- 3\. Renal impairment: eGFR \ 2.5 ULN at time of screening
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.