NCT05029570 Heart Rate Regularization in Atrial Fibrilation and Heart Failure
| NCT ID | NCT05029570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daniel Rodríguez Muñoz |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2022-04-29 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2022-04-29 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Fernando Arribas Ynsaurriaga, MD, PhD
STUDY CHAIR
Hospital Universitario 12 de Octubre
Frequently Asked Questions
Who can join the NCT05029570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05029570 currently recruiting?
Yes, NCT05029570 is actively recruiting participants. Contact the research team at danielantonio.rodriguez@salud.madrid.org for enrollment information.
Where is the NCT05029570 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05029570 clinical trial?
NCT05029570 is sponsored by Daniel Rodríguez Muñoz. The principal investigator is Fernando Arribas Ynsaurriaga, MD, PhD at Hospital Universitario 12 de Octubre. The trial plans to enroll 334 participants.
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