NCT06081049

The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Tor Biering-Sørensen · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is an investigator-initiated, prospective, randomized, double-blind, placebo-controlled study of the effects of colchicine in patients with HFpEF. The study population will consist of approx. 152 patients aged 40 years and above, who meet the criteria of HFpEF. Patients will be randomized to either low-dose colchicine treatment (0.5 mg once daily) or placebo and treatment will continue for 6 months. Patients will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and have echocardiography performed at baseline and after 6 months. Furthermore, the investigators will obtain office blood pressure, ECG, Myovista ECG, 6-minute walk test, pulse wave velocity (PWV), and blood samples at baseline and after 6 months.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Colchicine	0.5 mg once daily
DRUG	Placebo	Once daily

Timeline

• Start date: 2024-01-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-10-12
• Last updated: 2024-02-28

Locations

1 site across 1 country: Denmark