COLchicine and Thiamine in Heart Failure due to Ischemic Heart Disease (COLT-HF)

Phase 3

Recruiting

Conditions: Heart Failure

Registration Number: 2023-506675-96-00

Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary: In an RCT of individuals with HF secondary to ischemic heart disease (IHD):

1) To examine the impact of colchicine compared to placebo on the composite outcome of CV death, a HF event (defined a HF hospitalization or urgent HF visit), or ischemic cardiovascular events (myocardial infarction, ischemic stroke, or arterial revascularization).

2) To examine the impact of thiamine on the composite outcome of CV death, or HF hospitalization.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Age greater than or equal to 45 years

Documented ischemic heart disease as the etiology of HF, which includes: a) a history of CAD, and b) determination of the cause of HF to be due to IHD based on local investigator assessment

NYHA class II-IV symptoms

Documented LVEF less than or equal to 45% within 1 year prior to enrollment

Optimal medical treatment for HF as per local clinical practice

Participants can be enrolled in the ambulatory or hospitalized setting

Exclusion Criteria

Female who is pregnant, breast-feeding or is considering becoming pregnant during the study

Concurrent use of other experimental pharmacologic agents

Regular or required use colchicine or thiamine for other clinical indications

History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor

Use of a ventricular assist device or prior heart transplant

Severe valvular disease

Coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks.

Chronic and severe renal dysfunction defined as eGFR < 15 mL/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in

History of liver cirrhosis

Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of <2 years.

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)		Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)
Thiamine arm: Composite of CV death or HF event		Thiamine arm: Composite of CV death or HF event

Secondary Outcome Measures

Name	Time	Method
All cause death, hospitalization		All cause death, hospitalization
Serious adverse events		Serious adverse events
Side effects or adverse events resulting in study drug discontinuation		Side effects or adverse events resulting in study drug discontinuation

Trial Locations

Locations (17): Azienda Ospedaliero Universitaria Ospedali Riuniti
🇮🇹
Foggia, Italy
Azienda Sanitaria Locale Della Provincia Di Bari
🇮🇹
Bari, Italy
Azienda Unita Sanitaria Locale Della Romagna
🇮🇹
Rimini, Italy
Alessandro Manzoni Hospital
🇮🇹
Lecco, Italy
Azienda Ospedaliero Universitaria Delle Marche
🇮🇹
Ancona, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
🇮🇹
Catania, Italy
Azienda Socio Sanitaria Territoriale Della Valle Olona
🇮🇹
Busto Arsizio, Italy
Policlinico San Donato S.p.A.
🇮🇹
San Donato Milanese, Italy
Azienda USL IRCCS Di Reggio Emilia
🇮🇹
Reggio Emilia, Italy
Azienda Unita Sanitaria Locale Umbria 1
🇮🇹
Perugia, Italy
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Azienda Ospedaliero Universitaria Ospedali Riuniti
🇮🇹Foggia, Italy
Michele Correale
Site contact
0881732078
michele.correale@libero.it