Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

A vizsgálat adatai

Ki végzi

Montreal Heart Institute

Azonosító

NCT06217120

A regiszteradat frissítve

2026. november 10.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)

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).

Bevonási feltételek: Subjects ≥ 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. HF requiring hospitalization and IV diuretics within 12 months of study entry, or 2b. NTproBNP > 150pg/ml in sinus rhythm or NTproBNP > 450pg/ml in chronic atrial fibrillation, 3. The presence of coronary microvascular dysfunction (CMD) at baseline assessed using dipyridamole-based PET imaging and defined as myocardial functional reserve (MFR) < 2.0, 4. Symptoms of HF requiring current treatment with loop diuretics for ≥ 30 days, 5. NYHA functional class II to (ambulatory) IV, 6. High-sensitivity C-reactive protein (hs-CRP) > 5mg/L at baseline, 7. Subjects with the capacity to provide informed consent.

Kizáró feltételek: 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,; Patient currently taking colchicine for other indications (Familial Mediterranean Fever, gout or post MI). 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 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; Uncontrolled hypertension (systolic pressure of over 200 mmHg or a diastolic pressure of over 110 mmHg); Symptomatic hypotension; Untreated second- or third-degree atrioventricular block; Known hypersensitivity to dipyridamole; Caffeine intake in the previous 12 hours; Drug-drug interaction (competitive inhibition of CYP3A4 and P-gp): Patients treated with amiodarone, dronedarone, quinidine, propafenone, diltiazem, azithromycin or high-intensity statin therapy; Presence of primary severe valvular heart disease (functional MR/TR are not excluded),; 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, percutaneous intervention, or coronary artery bypass grafting),; History of hypersensitivity to colchicine,; Subject with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea,; Patient with pre-existent progressive neuromuscular disease,; Contra-indications to aminophylline use (PET-imaging): epilepsy, peptic ulcer (active) and hypersensitivity to aminophylline, theophylline, ethylenediamine, or any component of the formulation; History or presence of any other disease with a life expectancy of <1 year,; 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; or patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease,; 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,; Patients with a diagnosis of infiltrative cardiomyopathy,; 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; 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,; Patient considered by the investigator, for any reason, to be an unsuitable candidate for the study,.

ClinicalTrials.gov NCT06217120