NCT04996550

Brief Summary

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 with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,600

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jan 2022Dec 2028

First Submitted

Initial submission to the registry

July 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2028

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2028

Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

6 years

First QC Date

July 29, 2021

Last Update Submit

August 8, 2021

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • A combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.

    To compare the efficacy of carvedilol and metoprolol succinate in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.

    Four years with randomized cluster allocation and two year of follow-up.

Secondary Outcomes (2)

  • All-cause mortality.

    Four years with randomized cluster allocation and two year of follow-up.

  • A combined endpoint of all-cause mortality and first hospitalization for worsening heart failure according to heart rhythm (sinus rhythm or atrial fibrillation/flutter).

    Four years with randomized cluster allocation and two year of follow-up.

Other Outcomes (4)

  • Cost-effectiveness analysis of each strategy.

    Four years with randomized cluster allocation and two year of follow-up.

  • Proportion of patients who remained on beta-blocker treatment for a minimum of one year.

    Four years with randomized cluster allocation and two year of follow-up.

  • Proportion of patients who switched from their initially prescribed beta-blocker to the other.

    Four years with randomized cluster allocation and two year of follow-up.

  • +1 more other outcomes

Study Arms (2)

Carvedilol group

Treated with Carvedilol

Drug: Carvedilol

Metoprolol succinate group

Treated with Metoprolol succinate

Drug: Metoprolol Succinate

Interventions

CarvedilolDRUG

To compare the efficacy of carvedilol and metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.

Carvedilol group
Metoprolol SuccinateDRUG

To compare the efficacy of carvedilol and metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.

Metoprolol succinate group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All 23 danish departments of cardiology with a heart failure clinic associated, which report to the Danish Heart Failure Registry are eligible.

You may qualify if:

  • Age ≥18 years
  • NYHA ≥ II
  • LVEF ≤40%

You may not qualify if:

  • No indication for beta-blocker treatment or contraindications for the two for the two study drugs (Carvedilol or metoprolol succinate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Interventions

CarvedilolMetoprolol

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolamines

Central Study Contacts

Mikael K Poulsen

CONTACT

+45 24798402mikael.kjaer.poulsen1@rsyd.dk

Ann Banke

CONTACT

+45 26278303ann.banke@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 9, 2021

Study Start

January 3, 2022

Primary Completion (Estimated)

January 2, 2028

Study Completion (Estimated)

December 18, 2028

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Final results.

Locations

DK(1)