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NOT YET RECRUITING
NCT07904507
PHASE4

A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

Beta-blockers are generally prescribed for the treatment of atrial fibrillation. Their purpose is to slow the heart rate and thereby reduce the workload on the heart. However, beta-blockers can affect patients' quality of life, for example by reducing physical performance or causing fatigue in daily life. In this study, we aim to determine whether calcium channel blockers can improve the treatment of atrial fibrillation and have a positive impact on the quality of life of patients with atrial fibrillation compared with beta-blockers. We will also investigate how calcium channel blockers affect the physical exercise capacity. In addition, we will monitor potential side effects of both medications and explore whether there are any differences between women and men over the course of the study. Both study medications, the calcium channel blocker diltiazem and the beta-blocker bisoprolol, are approved by authorities and are recommended by the European Society of Cardiology for rate control in atrial fibrillation.

Official title: BRACE-AFib: Beta-blocker Replacement and Calcium Channel Blockers Evaluation in Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2026-11

Completion Date

2029-10

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Experimental intervention

Study participants randomized in the experimental intervention group will receive Non-dihydropyridine calcium channel blockers (NDCC) Diltiazem retard for 90 days. Depending on the dosage of the beta-blocker treatment of these patients at baseline, three different dosage options will be used (low, normal, high). Diltiazem capsules of 90mg will be provided, meaning that patients with the low dosage will take one capsule a day (morning), patients with the normal dosage two capsules a day (morning and evening) and patients with the high dosage four capsules a day (2x morning and 2x evening). Based on previous data, we assume that most patients will use the low or normal dosage. The medication Diltiazem 90mg will be over-encapsulated, packed and labelled by a pharmacy specialist.

DRUG

Control Intervention

Study patients will receive the beta-blocker (BB) Bisoprolol for 90 days. Depending on the dosage of the BB treatment of these patients at baseline, three different dosage options will be used (low, normal high). Low dosage of Bisoprolol is corresponding to 2.5mg, normal dosage to 5mg and high dosage to 10mg/day. Bisoprolol capsules of 2.5mg will be provided, meaning that patients with the low dosage will take one capsule a day (morning), patients with the normal dosage two capsules a day (morning and evening) and patients with the high dosage four capsules (2x morning and 2x evening). The medication Bisoprolol will be over-encapsulated, packed and labelled by a pharmacy specialist.

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland