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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.