HEART FAILUREPhase 3COLICANCT04705987
Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
A Phase 3 study testing Colchicine 0.5 MG in people with HEART FAILURE, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEART FAILURE
- What is being tested?
- Colchicine 0.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2021to 17 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
- Clinical evidence, by symptoms or signs, and / or radiological of congestion.
- NT-proBNP concentration greater than 900 pg / ml at screening visit.
- Age over 18 years.
- Patients who have given their informed consent in writing.
Who cannot join
- Severe valve disease with indication for surgical repair.
- Extracardiac disease with estimated vital prognosis of less than 1 year.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis), diarrhea chronic or malabsorption.
- Rheumatic inflammatory disease.
- Serious gastrointestinal disorders
- Stomach ulcer
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- Hematological disorders, such as blood dyscrasias
- Previous neuromuscular disease
- Severe renal failure (glomerular filtration rate <30 ml / kg / min / 1.73m2)
- History of cirrhosis, chronic active hepatitis or severe liver disease, defined by GOT (AST) or GPT (ALT) values that exceed 3 x upper limit of normality
- Patient who is taking colchicine for other indications (mainly chronic prescriptions for familial Mediterranean fever or gout). No washout period will be required for patients who have been treated with colchicine and have stopped treatment prior to randomization.
- Patient with a history of allergic reactions or significant sensitivity to colchicine.
- Chronic treatment with immunosuppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
- Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive test result for human chorionic gonadotropin (hCG), or planned become pregnant or plan to breastfeed during study treatment or within 30 days of the end of study drug treatment.
- Woman of childbearing potential who is unwilling to inform her partner of her participation in this clinical study or to use 2 effective contraceptive methods that are acceptable or to practice strict sexual abstinence (the investigator must assess the reliability of sexual abstinence and make it the preferred and usual lifestyle of the subject) during treatment with study drug (colchicine or placebo) and for an additional 30 days after the last dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Colchicine 0.5 MG, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Colchicine 0.5 mg/24h Treatment 8 weeks
PlaceboDrug
Placebo 1c/24h Treatment 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Colchicine 0.5 mg Receives: Drug: Colchicine 0.5 MG |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased NT-proBNP levels
Decreased (N-terminal prohormone of brain natriuretic peptide) levels
Measured: Up to 8 weeks
Secondary outcomes (9)
Improvement of clinical stability
dose of intravenous diuretics
Measured: Up to 8 weeks
Improvement of clinical stability
NYHA (New York Heart Association) Scale . Level 1 to 4. Level 1 is the one with the least limitation or symptoms.
Measured: Up to 8 weeks
Improvement of clinical stability
EVA scale . Level 1 to 10 . Level 1 is the one with the least pain, limitation or symptoms.
Measured: Up to 8 weeks
Improvement of clinical stability
LIKERT scale. Level 1 to 5 . Level 1 expresses the patient's agreement with a specific aspect.
Measured: Up to 8 weeks
Improvement of clinical stability
Number of Acute Decompensation Episodes
Measured: Up to 8 weeks
Improvement of clinical stability
Number of Congestion Episodes
Measured: Up to 8 weeks
Improvement of clinical stability
biomarkers (hsTnT, IL-1 beta, IL-6, sST2 y CA125.)
Measured: Up to 8 weeks
Mortality rate reduction
Measured: Up to 8 weeks
Total days of hospitalization
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start8 Feb 2021
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEART FAILUREStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domingo Pascual Figal, MD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705987
- Sponsor's protocol ID
- IMIB-CO-2020-01
- Acronym
- COLICA
- Status last verified
- Sep 2023
- First submitted
- 11 Jan 2021
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04705987
- Acronym / sponsor ID
- COLICA / IMIB-CO-2020-01
- Conditions
- HEART FAILURE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Colchicine 0.5 MGColchicine 0.5 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
- Clinical evidence, by symptoms or signs, and / or radiological of congestion.
- NT-proBNP concentration greater than 900 pg / ml at screening visit.
- Age over 18 years.
- Patients who have given their informed consent in writing.
Key exclusion criteria (15 listed)
- Severe valve disease with indication for surgical repair.
- Extracardiac disease with estimated vital prognosis of less than 1 year.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis), diarrhea chronic or malabsorption.
- Rheumatic inflammatory disease.
- Serious gastrointestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MGColchicine 0.5 mg/24h Treatment 8 weeks | Drug | Experimental |
| PlaceboPlacebo 1c/24h Treatment 8 weeks | Drug | Placebo |
Primary outcome
Decreased NT-proBNP levels
Time frame: Up to 8 weeks
Decreased (N-terminal prohormone of brain natriuretic peptide) levels
9 secondary outcomes
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Improvement of clinical stability
Time frame: Up to 8 weeks
Mortality rate reduction
Time frame: Up to 8 weeks
Total days of hospitalization
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domingo Pascual Figal, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG in people with HEART FAILURE, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased NT-proBNP levels (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.