RecruitingPhase 2Phase 3NCT06128980

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

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


Sponsor

Herlev and Gentofte Hospital

Enrollment

348 participants

Start Date

Jan 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether heart failure patients who developed their condition because of a fast, irregular heartbeat (called tachycardia-induced cardiomyopathy) can safely stop their heart failure medications after their heart has fully recovered. **You may be eligible if:** - You were diagnosed with new-onset heart failure with reduced pumping function (ejection fraction 40% or less) and atrial fibrillation or flutter causing a fast heart rate (110+ beats per minute) - After treating the arrhythmia, your heart has recovered (ejection fraction 50% or above), your heart volume has normalized, and your heart strain marker (NT-proBNP) is below 250 pg/mL - Your ECG has returned to normal **You may NOT be eligible if:** - You are under 18 or cannot consent - You have congenital heart disease, known genetic cardiomyopathy, or significant valve disease - You have cardiac amyloidosis, sarcoidosis, or other infiltrative heart diseases - Your kidneys function poorly (eGFR below 30) - You had a heart attack at the time your heart failure was diagnosed - You have a family member (first-degree relative) with dilated cardiomyopathy - Your heart failure may have been caused by alcohol, drugs, or medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGDMT

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


Locations(1)

Herlev-Gentofte Hospital

Copenhagen, Denmark

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NCT06128980


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