Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04705987
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2021-01-11
Brief Title:
Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Organization:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Overview
Official Title:
Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLICA
Brief 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-betaThe 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 05 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
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-betaThe 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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None