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New treatment option for Heart Failure
Official title Heart Rate Regularization in Atrial Fibrilation and Heart Failure
ClinicalTrials.gov ID: NCT05029570
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.