NCT04705987

Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) is a chronic disease associated with multiple acute decompensations, which are the main cause of hospital admission above 65 years and two thirds of the high costs associated with the disease. Furthermore, in the patient they reflect a phase of clinical instability, with a higher risk of early readmission (20-30% at 30 days) and higher mortality (10-15% at 30 days and 30-40% at 1year). However, the investigators do not have treatments specifically aimed at this unstable phase, known as acute or decompensated (HF). It is known that, in this acute and unstable state, there is an increase in inflammatory parameters. Indeed, our group has recently demonstrated the relevance of the interleukin-1 axis, in particular IL-1beta and sST2 concentrations identified a worse prognosis regardless of HF phenotype. Colchicine, a widely available drug, has proven to be a powerful cardiovascular anti-inflammatory, acting on inflammasome and therefore inhibiting the production of IL1-beta.The study hypothesis is that colchicine administered early during the acute phase can promote stability in terms of biomarkers of cardiac function and new decompensations. For this it is designed a randomized, double-blind clinical study with two arms (colchicine 0.5 mg vs. placebo) initiated within the first 24 hours of hospitalisation and administered for 60 days, in patients with acute decompensated HF with either reduced or preserved LV ejection fraction.

Detailed description

The primary objective of the study is the reduction of NT-proBNP at two months of treatment. A secondary objective is to attain a greater clinical stability, in terms of reduction of new HF decompensations and need for diuretics, and symptoms improvement. The calculated population size is 278 patients. Follow-up visits will be carried out at discharge, 7 days, 4 weeks and 8 weeks after the hospital discharge. The potential of the study is very high given the high prevalence and clinical impact of HF hospitalizations, together with the absence of specific treatment for this phase of the disease. Therefore, in case of a positive result, this would mean a huge clinical, social and health benefits, as well as being an important therapeutic progress.

Conditions

• HEART FAILURE

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG	Colchicine 0.5 mg/24h Treatment 8 weeks
DRUG	Placebo	Placebo 1c/24h Treatment 8 weeks

Timeline

• Start date: 2021-02-08
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2021-01-12
• Last updated: 2024-05-22

Locations

1 site across 1 country: Spain