The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorTor Biering-Sørensen
About this trial
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).
Eligibility criteria
Qualifiers
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)).
Disqualifiers
Colchicine treatment for another cause, e.g., gout
Allergy/hypersensitivity to colchicine
Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
Trial design
Treatments tested in this trial
- Colchicine
- Placebo
Treatment groups
152 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Source ClinicalTrials.gov