DUTCH Weight Control in Atrial Fibrillation Study

NCT ID: NCT06184633

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-21
• Study Completion Date: 2027-05-01

Brief Summary

Quantify the effect of an innovative weight loss management on rhythm control.

Detailed Description

Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.

Objective: Quantify the effect of an innovative weight loss management on rhythm control.

Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.

Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.

Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.

Main study parameters/endpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:

• Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)*
• AF despite pulmonary vein isolation
• AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
• AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
• Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation
• Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)
• Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation

• When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.

Conditions

Atrial Fibrillation; Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Semaglutide injections + combined lifestyle intervention

Group Type: ACTIVE_COMPARATOR

Semaglutide 3.2 MG/ML

Intervention Type: DRUG

Intervention arm receives semaglutide in addition to combined lifestyle intervention

Placebo

Placebo Semaglutide injections + combined lifestyle intervention

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Control arm receives placebo in addition to combined lifestyle intervention

Interventions

Semaglutide 3.2 MG/ML

Intervention arm receives semaglutide in addition to combined lifestyle intervention

Intervention Type: DRUG

Placebo

Control arm receives placebo in addition to combined lifestyle intervention

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -
• Age ≥ 18
• Obesity, as defined as:

• BMI ≥ 30 kg/m2, or
• BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)
• Scheduled ECV
• Written informed consent

Exclusion Criteria

• Permanent AF
• Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
• Current or previous treatment with amiodaron
• HbA1c ≥ 48 mmol/L, <3 months prior to randomization
• History of diabetes mellitus type 1 or 2
• Prior bariatric surgery
• Use of other anti-obesity medication, <3 months prior to enrollment
• Contra-indication for, or prior use of a GLP1-receptor agonist
• History of chronic pancreatitis or acute pancreatitis <6 months
• Acute coronary syndrome <6 months
• Severe (grade III) valvular disease
• eGFR <30 mL/min/1.73m2
• Heart failure NYHA class III-IV
• Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
• Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy <12 months, as judged by the treating physician.
• Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ron Pisters

Head of Cardioresearch and principal investigator, dr. R. Pisters

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ron Pisters, dr.

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Leonard Voorhout, MSc

Role: CONTACT

lvoorhout@rijnstate.nl

+31650818296

Other Identifiers

U1111-1275-9989

Identifier Type: -

Identifier Source: org_study_id