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NOT YET RECRUITING
NCT06637618
NA

Does the Sequence of Heart Failure Medication Matter

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

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

Official title: Cluster and Registry Trial Of the Working Group of Heart Failure in Denmark. Does the Strategy of Initiation of Heart Failure Medication Matter in the Real World.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16000

Start Date

2025-02-01

Completion Date

2030-02-01

Last Updated

2024-10-15

Healthy Volunteers

No

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