Prospective, single-center study of the effect on NT-proBNP levels of maintaining sinus rhythm after elective electrical cardioversion for persistent atrial fibrillation in patients with chronic heart failure and ejection fraction < 35%

Completed

• Conditions: Atrial fibrillation; chronic heart failure; 10019280

• Registration Number: NL-OMON40197
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Diagnosis of chronic heart failure with reduced ejection fraction (<35%) for at least one year, as determined before the episode of AF.
2. Persistent AF, with a minimal duration of 7 days and a maximal duration of 3 months, and with documented sinus rhythm before the episode of AF.
3. Successful ECV for persistent AF into sinus rhythm and maintaining sinus rhythm during at least 4 weeks of follow-up.
4. ICD or CRT-D implant present.
5. Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria

1. Hospitalization for heart failure in the previous 3 months before inclusion for another reason than for AF,.
2. Patients undergoing Continue Ambulant Peritoneal Dialysis (CAPD)/ Haemodialysis
3. Patient with a ST-segment-Elevated Myocardial Infarction (STEMI), CABG, PCI, CRT and/or valvular surgery within 1 month prior to ECV
4. Patients with planned Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Cardiac Resynchronization Therapy (CRT) and/or valvular surgery in the month after electrocardioversion.
5. Documented recurrence of AF of more than 24 hours per week in the last two weeks (or extended period) of follow-up.
6. Worsening of heart failure requiring hospitalization or visit to the emergency room for other reasons than for AF during the first two weeks, and for any reason during the third to sixth week of study period.
7. Spontaneous (documented) conversion to sinus rhythm before ECV.
8. Signed informed consent for any current interventional study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Significant reduction in NT-proBNP levels after ECV for persistent AF in<br /><br>patients with severe chronic heart failure and reduced ejection fraction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Significant reduction in NT-proBNP levels after electrical cardioversion for<br /><br>persistent AF in patients with severe chronic heart failure and reduced<br /><br>ejection fraction compared to patients with persistent AF and normal heart<br /><br>function.-<br /><br>- Significant change in cardiac output after ECV<br /><br>- Significant change in serum aldosterone levels after ECV</p><br>