The primary objective of the present study is to demonstrate that maintaining sinus rhythm after ECV for persistent AF in patients with severe chronic heart failure and reduced ejection fraction reduces NT-proBNP levels.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Significant reduction in NT-proBNP levels after ECV for persistent AF in
patients with severe chronic heart failure and reduced ejection fraction
Secondary outcome
- Significant reduction in NT-proBNP levels after electrical cardioversion for
persistent AF in patients with severe chronic heart failure and reduced
ejection fraction compared to patients with persistent AF and normal heart
function.-
- Significant change in cardiac output after ECV
- Significant change in serum aldosterone levels after ECV
Background summary
The occurrence of AF during chronic heart failure carries an increased risk of
mortality. In addition, atrial fibrillation can exacerbate heart failure.
Despite this, in a chronic heart failure patient setting, prognosis is not
changed whether a conservative or a rhythm control strategy is followed
Rhythm control therapy is known to significantly reduce NT-proBNP levels in
patients with AF without heart failure. To our knowledge no studies have been
performed yet to investigate the effect of ECV for persistent AF on NT-proBNP
levels in patients with severe chronic heart failure with reduced ejection
fraction (<35%). It is very well known in a chronic heart failure population
that NT-proBNP levels predict prognosis, and that the changes in NT-proBNP also
affect prognosis. If it can be demonstrated that NT-proBNP levels will be
reduced significantly after successful ECV in this population, the claim from
studies that demonstrate no benefit of rhythm control, should then be
reinterpreted.
Study objective
The primary objective of the present study is to demonstrate that maintaining
sinus rhythm after ECV for persistent AF in patients with severe chronic heart
failure and reduced ejection fraction reduces NT-proBNP levels.
Study design
Prospective, single-center study of the effect of maintaining sinus rhythm
after ECV for persistent AF on NT-proBNP levels in patients with severe chronic
heart failure and reduced ejection fraction.
Patients will be subjected to ECV for persistent AF. NT-proBNP levels will be
measured within 1 month and 30 minutes before ECV and 7 days and 1 month after
ECV. Interrogation of ICD/CRT devices will occur at 7 days, 14 days and 1
month after ECV. Echocardiography and Finapres measurements will be performed
within 1 month before and 1 month after ECV. Follow-up period can be extended
to 6 weeks when AF recurrence of more than 24 hours per week is detected on
ICD/CRT interrogation in the first two week of follow-up in order to ascertain
a 4-week period of maintaining sinus rhythm. Laboratory determination,
echocardiography and Finapress measurements are consequently postponed from 1
month to 6 weeks after ECV.
Study burden and risks
De patient zal tijdens de (dag)opname voor ECV en 1 tot maximaal 1,5 maand
daarna gevolgd worden voor dit onderzoek. Er zullen op 4 momenten 2 buisjes
bloed worden afgenomen voor dit onderzoek. Dit zal maximaal 8 mL per keer zijn
(ongeveer 2 eetlepels). De bloedafnames zullen wij zoveel mogelijk proberen te
combineren met de afnames die gepland zijn door uw behandelend arts. Hierdoor
proberen wij zoveel mogelijk te voorkomen dat de patient extra geprikt wordt
voor het onderzoek. Ook proberen wij de onderzoeken zoveel mogelijk met elkaar
te combineren zodat we proberen de ziekenhuisbezoeken tot een minimum te
beperken.
De patient krijgt daarnaast tweemaal een echo van het hart en een meting van de
druk in de slagader van de wijsvinger ondergaan. Het maken van een echo duurt
ongeveer 30 minuten en het meten van de druk in de slagader van de wijsvinger
enkele minuten. Beide onderzoeken zijn niet pijnlijk. Ook wordt uw ICD/CRT
enkele malen uitgelezen wat ongeveer 10 minuten zal duren.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44286.018.13 |