Heart Rate Regularization in Atrial Fibrilation and Heart Failure
Recruiting · NCT05029570 · Interventional (participants receive a specific treatment) · Lead sponsor: Daniel Rodríguez Muñoz
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level\>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.
Who can take part
Inclusion criteria
- Permanent atrial fibrillation
- At least one episode of hospitalisation due to heart failure in the previous 12 months.
- Left ventricular ejection fraction \> 40%
- Average resting heart rate ≤ 110 beats per minute
- NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
- Age ≥ 18 years
- Capacity to understand the nature of the study, legal ability and willingness to give informed consent.
Exclusion criteria
- Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to \< 12 months.
- Acute heart failure at the time of enrollment or systolic blood pressure \< 80 mmHg in the absence of inotropic agents.
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
- Severe mitral or aortic valvular heart disease
- Anaemia (Haemoglobin \< 10 g/dl)
- Morbid obesity (BMI ≥ 35)
- Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
- Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Simultaneous participation in a different trial
Where it is running
2 locations listed.
- Hospital Universitario 12 de Octubre - Madrid, Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Madrid, Spain