Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
302
Countries
2
Sites
12
Acute decompensated heart failure
To study if the administration of colchicine 0.5mg colchicine vs placebo in patients with decompensated HF is associated with decrease in NT-proBNP concentrations at 8 weeks after hospital discharge, as a biomarker of clinical stability and risk.
Key facts
- Sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia, Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 8 Feb 2021 → 30 Apr 2024
- Decision date (initial)
- 2023-05-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto de Salud Carlos III
External identifiers
- EU CT number
- 2023-504165-23-00
- EudraCT number
- 2020-000941-15
- ClinicalTrials.gov
- NCT04705987
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To study if the administration of colchicine 0.5mg colchicine vs placebo in patients with decompensated HF is associated with decrease in NT-proBNP concentrations at 8 weeks after hospital discharge, as a biomarker of clinical stability and risk.
Conditions and MedDRA coding
Acute decompensated heart failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10064653 | Acute decompensated heart failure | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
- 2. Clinical evidence, by symptoms or signs, and / or radiological of congestion.
- 3. NT-proBNP concentration greater than 900 pg / ml at screening visit.
- 4. Age over 18 years
- 5. Patients who have given their informed consent in writing.
Exclusion criteria 15
- 1. Severe valve disease with indication for surgical repair.
- 2. Extracardiac disease with estimated vital prognosis of less than 1 year.
- 3. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), diarrhea chronic or malabsorption.
- 4. Rheumatic inflammatory disease.
- 5. Serious gastrointestinal disorders
- 6. Stomach ulcer
- 7. Hematological disorders, such as blood dyscrasias
- 8. Previous neuromuscular disease
- 9. Severe renal failure (glomerular filtration rate <30 ml / kg / min / 1.73m2)
- 10. 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
- 11. 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.
- 12. Patient with a history of allergic reactions or significant sensitivity to colchicine.
- 13. Chronic treatment with immunosuppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
- 14. 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.
- 15. 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Decreased NT-proBNP levels
Secondary endpoints 3
- Improvement of clinical stability
- Mortality rate reduction
- Total days of hospitalization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
COLCHICINA SEID 0,5 mg comprimidos
PRD1784175 · Product
- Active substance
- Colchicine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 56 Day(s)
- Authorisation status
- Authorised
- ATC code
- M04AC01 — COLCHICINE
- Marketing authorisation
- 78947
- MA holder
- SEID, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Sponsor organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Address
- Carretera De Cartagena S/n, El Palmar El Palmar
- City
- Murcia
- Postcode
- 30120
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- Clinical trials unit
Public contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- Clinical trials unit
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Sponsor organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Address
- Carretera De Cartagena S/n, El Palmar El Palmar
- City
- Murcia
- Postcode
- 30120
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- Clinical trials unit
Public contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- Clinical trials unit
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 24 | 1 |
| Spain | Ended | 278 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Salamanca
Cardiology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Cardiology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Cardiology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
Cardiology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Germans Trias I Pujol
Cardiology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital De La Santa Creu I Sant Pau
Cardiology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario 12 De Octubre
Cardiology, Bloque D, Avenida De Cordoba S/n, Madrid
University Clinical Hospital Virgen De La Arrixaca
Cardiology, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital Universitario Reina Sofia
Cardiology, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2023-09-22 | 2024-04-30 | 2023-10-25 | 2024-03-18 | |
| Spain | 2021-02-08 | 2024-05-17 | 2021-02-08 | 2024-03-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results of the clinical trial SUM-50542
|
2024-10-09T12:31:27 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2025-05-07T12:39:43 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Resumen de resultados para personas legas_COLICA_es | 1 |
| Summary of results (for publication) | Summary of results of the clinical trial | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-21 | Spain | Acceptable 2023-03-03
|
2023-03-03 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-03-06 | 2023-05-19 | ||
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-25 | 2023-05-25 |