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NCT06637618Not yet recruiting

Does the Sequence of Heart Failure Medication Matter

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.

Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
16000 (estimated)
First submitted
13 Sept 2024
Start date
1 Feb 2025
Primary completion date
31 Jan 2029
Lead sponsor
Aarhus University Hospital
NCT number
NCT06637618

What you commit to

  • Study type: Interventional
  • Planned participants: 16000
  • From 1 Feb 2025 to the primary completion date, 31 Jan 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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Who the study is looking for

  • All patients ≥18 years old who are newly diagnosed with HFrEF and allocated to an outpatient clinic for up-titration of guideline-directed medical therapy for HFrEF at participating cardiology departments

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.