The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Herlev and Gentofte Hospital
RECRUITING
Hellerup
Contact Information
Primary
Camilla Ikast Ottosen, MD
camilla.ikast.ottosen@regionh.dk
+4560222922
Backup
Tor Biering-Sørensen, MD, PhD, MPH
tor.biering-soerensen@regionh.dk
+4528933590
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2026-06
Participants
Target number of participants: 152
Treatments
Experimental: Colchicine
Colchicine 0.5 mg once daily
Placebo_comparator: Placebo
Placebo once daily
Sponsors
Leads: Tor Biering-Sørensen

This content was sourced from clinicaltrials.gov