Does the Sequence of Heart Failure Medication Matter

Summary

This study will tests whether a strategy of upfront prescription of mineralocorticoid receptor antagonists (MRA) is different from usual care, where MRA are usually prescribes as the last drug of the four drug classes used in the treatment of heart failure with reduced cardiac pump function (ace-inhibitor, beta blocker, sodium-glucose-2 inhibitors, MRA).

The study is a national study that intends to include all adult Danish patients diagnosed with heart failure and reduced pump function from early 2025 til early 2029.

Treatment strategy will be decided by randomisation, where each heart failure clinic is randomised to one of the two strategies (upfront MRA vs. usual care) for one year, followed by cross-over to the other treatment strategy for one year.

Patients will be followed according to usual care at their respective heart failure clinic. Study-specific followup will be conducted through the Danish registries for a minimum of two years.

The primary goal of the study is to evaluate whether one of the two treatment strategies leads to fewer hospitalisations for heart failure and/or death at one year after study entry.

Other goals of the study is to evaluate whether one of the two strategies leads to less kidney disease, improved quality of life and improved cost-effectiveness

Conditions

• Heart Failure, Reduced Ejection Fraction

Interventions

BEHAVIORAL

up front use of mineralocorticoid receptor antagonist

the sequence of which the four drug classes are prescribed will differ, where the intervention is early use of MRA, where the control group will receive standard care, where MRA are usually prescribed last

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Naestved Hospital

  collaborator OTHER

• Svendborg Hospital

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Aabenraa Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Regionshospital Nordjylland

  collaborator OTHER_GOV

• Hospitalsenheden Vest

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2029-01-31

Completion

2030-02-01