Heart Failure With Preserved Ejection Fraction study: Colchicine
Official title Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT06217120
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, being studied as a potential treatment for heart failure with preserved ejection fraction.
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
- This study will evaluate the impact of colchicine on the change in myocardial flow reserve (MFR), a marker for coronary microvascular dysfunction (CMD), compared to a matched placebo in patients with heart failure and ejection fraction above 40% (including patients with improved EF).
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- people ≥ 40 years of age,
- Chronic symptomatic HF and left ventricular ejection fraction (LVEF) \> 40% within 12 months prior to screening visit (regardless of the imaging...
You likely can't join if
- Patients with a diagnosis of infiltrative cardiomyopathy,
- Presence of primary severe valvular heart disease (functional MR/TR are not excluded),
- Presence of active infection within the 3 months prior to enrollment needing antibiotics,
- Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent PCI within the 3...
- Known or clinically judged significant (i.e., angina with CCS class \> 2/4) epicardial coronary artery disease (CAD) that has not been revascularized...
- History of hypersensitivity to colchicine,
See the full eligibility criteria
- people ≥ 40 years of age,
- Chronic symptomatic HF and left ventricular ejection fraction (LVEF) \> 40% within 12 months prior to screening visit (regardless of the imaging modality) and one of the following abnormalities: 2a.
- Patients with a diagnosis of infiltrative cardiomyopathy,
- Presence of primary severe valvular heart disease (functional MR/TR are not excluded),
- Presence of active infection within the 3 months prior to enrollment needing antibiotics,
- Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent PCI within the 3 months prior to enrollment,
- Known or clinically judged significant (i.e., angina with CCS class \> 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction...
- History of hypersensitivity to colchicine,
- Evidence of hepatic disease as determined by any 1 of the following: SGOT (AST) or SGPT (ALT) values exceeding 3× the upper limit of normal at enrollment
- Patients with at most moderate renal impairment defined as an eGFR \< 59 ml/min/1.73 m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at enrollment,
- Subject with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea,
- Patient with pre-existent progressive neuromuscular disease,
- Patient currently taking colchicine for other indications (Familial Mediterranean Fever, gout or post MI).
- Patients under long-term systemic steroid medication or any chronic use of anti- inflammatory medication (including Non-steroidal Anti-inflammatory Drugs, NSAIDS),
- Contra-indications to dipyridamole use (PET-imaging): Patients with bronchospastic lung disease with ongoing wheezing; Acute myocardial infarction or unstable angina in the past 48h
- Contra-indications to aminophylline use (PET-imaging): epilepsy, peptic ulcer (active) and hypersensitivity to aminophylline, theophylline, ethylenediamine, or any component of the formulation
- Positive pregnancy test result at the screening visit, and females of childbearing potential who do not agree to use adequate method of contraception for the duration of the study
- History or presence of any other disease with a life expectancy of \<1 year,
- Patient considered by the investigator, for any reason, to be an unsuitable candidate for the study,
- Drug-drug interaction (competitive inhibition of CYP3A4 and P-gp): Patients treated with amiodarone, dronedarone, quinidine, propafenone, diltiazem, azithromycin or high-intensity statin therapy.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. 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.