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โ† Trials
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Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllHerlev and Gentofte Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients with new onset heart failure (ambulatory or hospital) with reduced ejection fraction (LVEFโ‰ค40% assessed by echocardiography) and NYHA โ‰ฅ2 and atrial fibrillation or atrial flutter with ventricular rate โ‰ฅ110 bpm (ECG monitoring, hospital telemetry or Holter monitoring) that following GDMT - while AF is terminated (e.g. ablation or conversion) or controlled (HR\<110 on resting ECG) - experience LVEF remission (LVEF โ‰ฅ50%), normalization of indexed LV volume, and normal ECG (no bundle branch block, ST segment deviations or T-wave inversion) and NT-proBNP \<250 pg/ml. Exclusion Criteria: * 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) * Previously genotyped positive for genes known to cause cardiomyopathy * Probable hypertrophic, restrictive or non-compaction cardiomyopathy * Moderate/severe valvular disease * Suspicion of or known cardiac amyloidosis, sarcoidosis, or other storage/inflammatory disease * More than 10% PVCs or documented sustained ventricular arrhythmias * History of persistent or permanent AF with ventricular rates \>110 before incident HF despite best standard of care * eGFR \< 30 ml/min/1.73 m2 * Acute myocardial infarction at index * Probable medication-, alcohol- or illicit drug use induced AF and/or HF * Systolic blood pressure \>160 mmHg (at multiple measurements) at index or history of uncontrollable hypertension * Myocarditis * Cardiogenic shock at index * Aborted sudden cardiac death * Pacing-induced cardiomyopathy * 1.st degree relative with DCM
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What it tests

  • GDMT
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Where

1 site
Herlev-Gentofte Hospital
Copenhagen, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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