Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital

About this trial

New onset heart failure (HF) is observed in up to 25% of patients with incident atrial fibrillation or flutter (AF). Current guidelines suggest that both conditions (AF \& HF) be addressed with guideline directed medical therapy (GDMT) for HF and rate or rhythm control of AF. Hence, patients with both conditions are subjected to extensive polypharmacy with possible prognostic benefits, but also possible side effects, such as decreased renal function, dizziness, tiredness and hypotension, as well as the financial burden on both the individual patients and society, in addition to the stigma of having a HF diagnosis.

Guidelines do not inform how to manage long-term patients with HF, who following control of the incident tachycardia (e.g. AF), show full recovery from their HF condition.

This investigator-initiated, open-label, randomized, non-inferiority trial will test whether incremental weaning of GDMT in patients following full cardiac recovery and AF control is non-inferior compared to continuous GDMT with respect to the primary endpoint of freedom from heart failure deterioration. Furthermore, this study seeks to extensively phenotype these patients (genetic testing, advanced imaging, biomarkers etc.) in order to establish whether certain phenotypes are at lesser or greater risk of deterioration once remission is established. This novel approach of a personalized treatment regimen depending on e.g. genetic profiling could lead to an aggressive treatment in patients at high risk of deterioration and conversely spare patients with a negligible risk, a life-long intensive treatment regimen.

All HF clinics located in Zealand, Denmark, with a catchment area of \>2 million citizens, have agreed to participate in the WEAN-HF trial. A total of 348 patients will be randomized. Patients are followed up the 1st year after randomization with clinical examination, biomarkers and echocardiography, and are subsequently followed via Danish nationwide registries for 10 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

18 years or older and able to consent

Former ablation procedures and inability to tolerate antiarrhythmic drugs

Pregnancy

Congenital heart disease (congenital defects with no hemodyamic effects are not excluded)

Trial design

Design model

Parallel

Treatments tested in this trial

  • GDMT

    Drug

    Sequential weaning starting with SGLT2i - MRA - BB - ACEi/ARB/ARNi

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: WeaningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patients free from heart failure deterioration 1 year after randomization

Heart failure deterioration is defined as following; a reduction in LVEF of more than 10% and less than 50%, and/or increase in LVEDV by more than 10% and to higher than the normal range (indexed for body surface area), and/or hospitalization for heart failure and/or arrhythmia, and/or clinical evidence of heart failure.

Time frame
1 year after randomization

Secondary outcomes

1

Changes in Minnesota Living with Heart Failure Questionnaire from baseline

Between group changes will be analysed

Time frame
1 year after randomization
2

Cardiovascular (CV) hospitalizations

Time to 1st and total urgent CV hospitalizations (AF, HF, MI or stroke)

Time frame
1 year after randomization
3

Non-CV hospitalizations

Time to 1st and total non-CV hospitalizations

Time frame
1 year after randomization + 10 year follow-up
4

CV death

Incidence rates with between group comparisons

Time frame
1 year after randomization + 10 year follow-up

Other outcomes

1

Patients with renal deterioration, hypotension, dizziness.

Between group comparisons

Time frame
1 year after randomization
2

Patients with signs of new onset liver affection and/or thyroid dysfunction

Between group comparisons

Time frame
1 year after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Herlev and Gentofte Hospital

Lead sponsor

Nordsjaellands Hospital

Collaborator

University Hospital Bispebjerg and Frederiksberg

Collaborator

Zealand University Hospital

Collaborator

Copenhagen University Hospital, Hvidovre

Collaborator