SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation

NCT07445789 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: SMART-VERAPAF101410224100312025-524245-27-00
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief Summary

The SMART-VERAPAF study investigates the effects of different heart rate-lowering medications in patients with paroxysmal atrial fibrillation (AF). This heart rhythm disorder is associated with a large number of emergency room visits and hospitalizations for cardioversions and ablations. In this study, patients with symptomatic paroxysmal AF are randomized to treatment with heart rate reduction using verapamil or metoprolol, both licensed for this indication. In addition, in a subset of patients, the effect of centrally guided self-care using smartwatch data will be evaluated. The hypothesis is that both verapamil and guided self-care will lead to better heart rate control and fewer cardioversions and pulmonary vein ablations in patients with paroxysmal AF. This will also result in fewer hospital admissions, outpatient visits, and costs, as well as improved quality of life.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; verapamil; metoprolol; rate control; rhythm control; paroxysmal

Outcome Measures

Primary Outcomes (1)

• The time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation

  follow-up duration is at least 1 year after randomisation and can range from 1 to 3 years

Study Arms (2)

verapamil

EXPERIMENTAL

rate control with verapamil 240 mg od

Drug: Verapamil 240 mg slow-release tablet

metoprolol

ACTIVE COMPARATOR

rate control with metoprolol 100 mg od

Drug: metoprolol 100 mg slow-release tablet

Interventions

Verapamil 240 mg slow-release tablet DRUG

rate control with verapamil 240 mg od

verapamil

metoprolol 100 mg slow-release tablet DRUG

Rate control with metoprolol 100 mg od

metoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age ≥ 18 years old
• ECG documented diagnosis of paroxysmal AF
• Presence of symptomatic paroxysmal AF, defined as recurrent self-terminating AF (≥ 2 episodes in last 4 months) documented by typical symptoms, ECG or photoplethysmo-gram
• Able and willing to sign informed consent.
• For SMART sub study only:
• \- Own a smartphone

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• A history of electrical cardioversion for persistent AF
• History of AF episode \> 7 days
• Previous or current chronic amiodaron use.
• A history of pulmonary vein ablation
• Taking part in another randomized trial
• Reduced life-expectancy of \< 1 year
• Presence of contra-indication for verapamil or metoprolol
• Pregnant or breastfeeding women. Or women who are planning to become pregnant during the study period.
• For substudy patients: already participating in an eHealth program
• Contraindications for verapamil or metoprolol:
• Known hypersensitivity, intolerance or allergy to verapamil, metoprolol, or any excipi-ents.
• Current use of verapamil, diltiazem, beta-blockers or digoxin, or \< 5 half-lives ago at the time of randomization.
• Concomitant use of medications with absolute contraindications for verapamil or metoprolol (e.g., strong CYP3A4 inhibitors).\*
• Resting heart rate \< 50 beats per minute at baseline.

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Related Links

• Dutch description of the study on Funding Organisation of the Dutch Government

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Verapamil; Metoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols

Study Officials

• Robert G Tieleman, MD, PhD

  Martini Hospital Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert G Tieleman, MD, PhD

CONTACT

+31505245245; r.tieleman@gmail.com

Scientific Department Martini Hospital

CONTACT

+31505246311; wetenschap@mzh.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomised controlled trial comparing 2 medications

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 12 months following publication of the primary results and ending 5 years after publication.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal. Proposals should be directed to the PI (r.tieleman@gmail.com). To gain access, requestors will need to sign a data access agreement. Data will be shared for the purpose of achieving the aims outlined in the approved proposal.