Heart Rate Regularization in Atrial Fibrilation and Heart Failure (NCT05029570) | Clinical Trial Compass
RecruitingNot Applicable
Heart Rate Regularization in Atrial Fibrilation and Heart Failure
Spain334 participantsStarted 2022-04-29
Plain-language summary
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 participate
Age range18 Years
SexALL
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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