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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Colchicine
Drug0.5 mg once daily
Placebo
DrugOnce daily
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: ColchicineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Time frame
6 monthsSecondary outcomes
1
Between-group difference in change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Time frame
6 months2
Between-group difference in the proportion of patients with a ≥ 5-point increase in KCCQ-CS and KCCQ-OS at 6 months
The Kansas City Cardiomyopathy Questionnaire scores are scaled from 0-100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; 75 to 100; good to excellent.
Time frame
6 monthsOther outcomes
1
Between-group difference in change in office-measured systolic blood pressure at 6 months
Time frame
6 months2
Between-group difference in change in office-measured diastolic blood pressure at 6 months
Time frame
6 months3
Between-group difference in change in exercise capacity assessed by 6-minute walk test at 6 months
Time frame
6 months4
Between-group difference in change in LV mass index assessed by echocardiography at 6 months
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Source ClinicalTrials.gov