Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
Status:
Not yet recruiting
Trial end date:
2032-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Herlev and Gentofte Hospital
Collaborators:
Copenhagen University Hospital, Hvidovre Nordsjaellands Hospital University Hospital Bispebjerg and Frederiksberg Zealand University Hospital