Status:
NOT_YET_RECRUITING
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Montreal Heart Institute
Conditions:
Heart Failure With Preserved Ejection Fraction
Microvascular Coronary Artery Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the impact of colchicine on the change in coronary flow reserve (CFR), a marker for coronary microvascular dysfunction (CMD), compared to placebo in patients with heart failur...
Detailed Description
This will be a pilot mechanistic study. Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 milligram (mg) daily or a matched placebo. Follow-up will occur six months after ran...
Eligibility Criteria
Inclusion
- Subjects ≥ 40 years of age,
- Chronic symptomatic HF and left ventricular ejection fraction (LVEF) \> 40% within 12 months prior to the screening visit (regardless of the imaging modality) documented by one of the following:
- HF requiring hospitalization and IV diuretics within 12 months of study entry, or
- NTproBNP \> or = 150pg/ml in sinus rhythm or NTproBNP \> or = 450pg/ml in chronic atrial fibrillation,
- New York Heart Association Class, NYHA functional class II to (ambulatory) IV,
- Evidence of pathological systemic inflammation: high C-reactive protein, hs-CRP levels (hs-CRP \> or = 5mg/L),
- Subjects with the capacity to provide informed consent.
Exclusion
- Patients with a diagnosis of infiltrative cardiomyopathy,
- Presence of severe valvular heart disease,
- Presence of active infection within the 3 months prior to enrollment needing antibiotics (excluding COVID (Coronavirus disease)-19),
- Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to enrollment,
- Known or clinically judged significant (i.e., angina with CCS (Canadian Cardiovascular Society) class \> 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction, percutaneous intervention, or coronary artery bypass grafting),
- History of hypersensitivity to colchicine,
- Evidence of hepatic disease as determined by any 1 of the following: AST or ALT values exceeding 3× the upper limit of normal at enrollment; or patient with a history of cirrhosis, chronic active hepatitis, or severe hepatic disease,
- Patients with estimated glomerular filtration rate (eGFR) \<30 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 (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment,
- Patients under long-term steroid medication for a chronic condition,
- Contraindication to dipyridamole-containing medication, acute myocardial infarction or unstable angina in the past 48h,
- Positive pregnancy test results at the screening visit, and females of childbearing potential who do not agree to use adequate methods of contraception for the duration of the study; acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner,
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06217120
Start Date
March 1 2024
End Date
March 1 2026
Last Update
January 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8