DUTCH Weight Control in Atrial Fibrillation Study

NCT06184633 | Recruiting Phase 4 DMC

• 1 other identifier: U1111-1275-9989
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1 year follow-up

Secondary Outcomes (11)

• Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.

  week 0 and 52

• Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.

  week 0 and 52

• Number of hospitalizations because of an AF recurrence.

  week 0-52

• Number of unscheduled hospital visits because of adverse events of AAD.

  week 0-52

• Number of scheduled electrical cardioversions.

  week 0-52

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Semaglutide injections + combined lifestyle intervention

Drug: Semaglutide 3.2 MG/ML

Placebo

PLACEBO COMPARATOR

Placebo Semaglutide injections + combined lifestyle intervention

Drug: Placebo

Interventions

Semaglutide 3.2 MG/ML DRUG

Intervention arm receives semaglutide in addition to combined lifestyle intervention

Intervention

Placebo DRUG

Control arm receives placebo in addition to combined lifestyle intervention

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Obesity; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Study Officials

• Ron Pisters, dr.

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard Voorhout, MSc

CONTACT

+31650818296; lvoorhout@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardioresearch and principal investigator, dr. R. Pisters

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: July 21, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)