Actively Recruiting
Heart Rate Regularization in Atrial Fibrilation and Heart Failure
Led by Daniel Rodríguez Muñoz · Updated on 2025-09-09
334
Participants Needed
1
Research Sites
435 weeks
Total Duration
On this page
Sponsors
D
Daniel Rodríguez Muñoz
Lead Sponsor
S
Sociedad Castellana de Cardiologia
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Heart Rate Regularization in Atrial Fibrilation and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 110 beats per minute
- NT-proBNP 65 900 pg/ml in the 30 days prior to enrollment
- Age 65 18 years
- Capacity to understand the nature of the study, legal ability and willingness to give informed consent
You will not qualify if you...
- Severe frailty (Clinical Frailty Scale 64 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 64 20 ml/1,73 m2)
- Severe mitral or aortic valvular heart disease
- Anaemia (Haemoglobin < 10 g/dl)
- Morbid obesity (BMI 65 35)
- Severe Chronic Obstructive Pulmonary Disease (Gold 65 3)
- Presence of a different indication for pacing or implantable cardioverter-defibrillator (ICD)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Simultaneous participation in a different trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
Research Team
D
Daniel Rodriguez Muñoz, MD, PhD
CONTACT
A
Ana Isabel Castillo Varón, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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