Overview
Sponsor-declared trial summary
Heart Failure
The objective of CROWD-COMPARE is to compare the efficacy of Carvedilol and Metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients followed in a heart failure clinic, who have an indication for treatment with beta-blockers due to heart failure with reduced ejection …
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Mar 2024 → ongoing
- Decision date (initial)
- 2023-06-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-503010-23-01
- ClinicalTrials.gov
- NCT04996550
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The objective of CROWD-COMPARE is to compare the efficacy of Carvedilol and Metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients followed in a heart failure clinic, who have an indication for treatment with beta-blockers due to heart failure with reduced ejection fraction.
Secondary objectives 1
- None
Conditions and MedDRA coding
Heart Failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients who are registered in the Danish Heart Failure Registry with reduced ejection fraction who have claimed at least one prescription for either Carvedilol or Metoprolol succinate.
Exclusion criteria 1
- Patients who have filled in a prescription for Carvedilol or Metoprolol succinate before the date of first registered visit in the Danish Heart Failure Registry and patients who have opted out of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint will be a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.
Secondary endpoints 1
- 1) All-cause mortality. 2) A combined endpoint of all-cause mortality or first hospitalization for worsening heart failure according to heart rhythm (sinus rhythm or atrial fibrillation/flutter).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Metoprololsuccinat AL 190 mg Retardtabletten
PRD1972309 · Product
- Active substance
- Metoprolol Succinate
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 190 mg milligram(s)
- Max total dose
- 190 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB02 — METOPROLOL
- Marketing authorisation
- 76463.00.00
- MA holder
- ALIUD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carvedilol Mylan 25 mg, filmomhulde tabletten
PRD10093368 · Product
- Active substance
- Carvedilol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AG02 — CARVEDILOL
- Marketing authorisation
- RVG 30019
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Department of Cardiology
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Department of Cardiology
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 5,600 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2024-03-20 | 2024-06-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-08 | Denmark | No conclusion 2023-06-13
|
2023-06-16 |