DUTCH Weight Control in Atrial Fibrillation Study

Obesity Clinical Trial

— DUTCH-WAIST  

Official title:

DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184633
• Other study ID #: U1111-1275-9989
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: January 2024
• Source: Rijnstate Hospital
• Contact: Leonard Voorhout, MSc
• Phone: +31650818296
• Email: lvoorhout[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Body Weight
• Obesity
• Weight Loss

Intervention

Drug:
• Semaglutide 3.2 MG/ML
Intervention arm receives semaglutide in addition to combined lifestyle intervention
• Placebo
Control arm receives placebo in addition to combined lifestyle intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.	EHRA: European Heart Rythm Association; 1= no symptoms 2a= mild symptoms; Normal dialy activity not affected, symptoms not troublesome to patient 2b= moderate symptoms; Normal daily activity not affected but patient troubled by symptoms 3= severe symptoms; Normal daily activity affected 4= disabling symptoms; Normal daily activity discontinued	week 0 and 52
Secondary	Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.	Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension.; LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems	week 0 and 52
Secondary	Number of hospitalizations because of an AF recurrence.		week 0-52
Secondary	Number of unscheduled hospital visits because of adverse events of AAD.		week 0-52
Secondary	Number of scheduled electrical cardioversions.		week 0-52
Secondary	Number of unscheduled electrical cardioversions.		week 0-52
Secondary	Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).		week 0-52
Secondary	Total number of unscheduled cardioverions.		week 0-52
Secondary	Change in waist circumference, measured in cm		week 0 and 52
Secondary	Change in weight, measured in % and kg		week 0 and 52
Secondary	Change in BMI, measured in kg/m2		week 0 and 52