The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
Denmark152 participantsStarted 2024-01-18
Plain-language summary
The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF).
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* LVEF ≥ 45% judged by echocardiography during the screening epoch or within 6 months prior to screening visit
* Symptom(s) of heart failure for at least 30 days prior to screening visit and current symptoms of heart failure (NYHA functional class II-IV) at screening visit
* Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures (left atrial enlargement and/or left ventricular hypertrophy) judged by echocardiography at screening epoch or within 12 months prior to screening visit
* Raised pro-BNP ≥ 125 pg/ml (sinus rhythm) or ≥ 300 pg/ml (atrial fibrillation (AF)).
* Body Mass Index (BMI) \< 40 kg/m2 at screening visit
* Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
* Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
Exclusion Criteria:
* Colchicine treatment for another cause, e.g., gout
* Allergy/hypersensitivity to colchicine
* Uncontrolled hypertension (systolic BP \>180 mmHg or diasto…
What they're measuring
1
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) at 6 months