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Withdrawal of pharmacological treatment for heart failure in patients with atrial fibrillation and heart failure with improved cardiac function after ablation for atrial fibrillation: an open-label, pilot, randomized trial

Withdrawal of pharmacological treatment for heart failure in patients with atrial fibrillation and heart failure with improved cardiac function after ablation for atrial fibrillation: an open-label, pilot, randomized trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077439
Enrollment
Unknown
Registered
2023-11-08
Start date
2023-04-13
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Intervention group:Withdrawal of pharmacological treatment for heart failure
Control group:Continuing pharmacological treatment of HF

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Age 18-80 years old 2: Catheter ablation of atrial fibrillation or atrial flutter 3 months ± 1 month ago 3: Patients with echocardiographic LVEF = 45% 12 months before catheter ablation, and those who can tolerate ablation with or without phamarcological treatment for heart failure 4: Taking guideline-directed medical therapy after ablation 5: Baseline echocardiographic LVEF = 55% and LVEDD within the normal range 6: Baseline NT-proBNP <250ng/L 7: Absence of current symptoms and signs of heart failure 8: Current treatment with a loop diuretic, ARNI/ACEI/ARB, beta-blocker, mineralocorticoid receptor antagonist (MRA), or SGLT2i, or a combination of these drugs 9: Informed and agree to participate in this study

Exclusion criteria

Exclusion criteria: 1: With other clearly diagnosed cardiomyopathy 2: Diagnosis of heart failure before the diagnosis of atrial fibrillation or atrial flutter 3: Atrial fibrillation, atrial flutter, or atrial tachycardia at 3 months ± 1 month after catheter ablation 4: With frequent premature ventricular contractions, ventricular tachycardia, atrioventricular or atrioventricular nodal reentry tachycardia 5: Imaging diagnosis of coronary heart disease 6: Uncontrolled hypertension (blood pressure >160/100 mm Hg) 7: Valvular disease of moderate or greater severity 8: Estimated glomerular filtration rate less than 30 mL/min per 1·73 m2 9: Planned heart surgery within 1 year 10: Pregnancy 11: Life expectancy < 1 year (such as malignant tumors, etc.)

Design outcomes

Primary

MeasureTime frame
Relapse of heart failure;

Secondary

MeasureTime frame
Composite endpoint of cardiovascular death, non fatal stroke, non fatal myocardial infarction, and hospitalization due to heart failure;Ultrasound: LVEF, LVEDD;Changes of NT-pro-BNP concentration between baseline and follow-up;Changes of scores of Kansas City Cardiomyopathy Questionnaire;Atrial fibrillation burden;Adverse drug reactions;MRI: LVEF, LVEDVi, LAVi, T1 time;Resting heart rate;Systolic and diastolic blood pressure;

Countries

China

Contacts

Public ContactCaihua Sang

Beijing Anzhen Hospital, Capital Medical University

sch9613070@sina.com+86 134 3908 0206

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 28, 2026