Status:
WITHDRAWN
Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
Lead Sponsor:
Axel Brandes
Collaborating Sponsors:
Herlev and Gentofte Hospital
Hillerod Hospital, Denmark
Conditions:
Atrial Fibrillation
Overweight and Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to...
Detailed Description
The SOCRATES-AF pilot study is a prospective, parallel-group, double-blind, randomized controlled trial in patients with paroxysmal or early persistent atrial fibrillation and overweight and obesity. ...
Eligibility Criteria
Inclusion
- Signed informed consent before any study-related activity
- ≥ 18 years of age at the time of signing informed consent
- Body mass index (BMI) ≥ 30 kg/m2
- Body mass index (BMI) ≥ 27 kg/m2 and at least 1 concomitant cardiometabolic risk factor (hypertension, dyslipidemia, or obstructive sleep apnea)
- Symptomatic paroxysmal or early persistent atrial fibrillation (Paroxysmal AF: Self- terminating, in most cases within 48 hours up to 7 days. AF episodes that are cardioverted within 7 days with a documented 12 lead ECG showing sinus rhythm within the last 12 months; early persistent AF: AF episodes lasting longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Early persistent AF in this trial is defined as persistent AF with first-time electrical cardioversion (ECV) or a maximum of 1 previous ECVs.)
Exclusion
- General exclusion criteria
- Age ≥75 years
- History of type 1 or 2 diabetes (history of gestational diabetes is allowed)
- Known or suspected hypersensitivity to study medication or related products
- Treatment with GLP-1 receptor agonists within the last 3 months before randomisation
- Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors
- Alcohol/drug abuse
- Pregnant or breastfeeding women
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, sub- dermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Active malignancy, unless in complete remission for ≥5 years
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- Inflammatory bowel diseases
- Acute or chronic pancreatitis
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
- Current history of treatment with medications that may cause significant weight gain, within the last 3 months before screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening
- Current participation (or within the last 3 months) in an organised weight reduction programme or currently using or used within 3 months before screening: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine (either by prescription or as part of a clinical trial)
- Severe chronic obstructive pulmonary disease
- Uncontrolled treated/untreated hypertension (systolic \>180 mmHg and/or diastolic \>105 mmHg)
- Previous or planned surgical treatment for obesity
- Life expectancy \<2.5 years
- Other concomitant disease or treatment that according to the investigator's assessment makes the subject unsuitable for study participation
- Participation in any other clinical intervention trial
- Previous participation in the SOCRATES-AF pilot study
- Inability to sign informed consent
- Exclusion criteria related to a cardiac condition
- Previous or planned AF ablation
- Previous use of continuous prophylactic class I or III antiarrhythmic drugs
- Long-standing persistent or permanent AF
- Overall clinical history of persistent AF ≥5 years
- ECG suggestive of malignant ventricular arrhythmia
- Prolonged corrected QT-interval (\>500 ms), unless caused by bundle branch block
- Myocardial infarction (MI) within the last 3 months before screening
- Coronary revascularization within the last 3 months before screening
- Planned coronary revascularisation
- Cardiac surgery within the last 12 months before screening
- Obstructive hypertrophic cardiomyopathy
- Clinically significant valvular heart disease
- Left ventricular (LV) dysfunction (HFrEF with left ventricular ejection fraction (LVEF) \<45%) unless elicited by AF
- Hospitalization due to decompensated heart disease within 30 days prior to randomization
- Congestive heart failure (NYHA class IV)
- Current myocardial or pericardial infection
- Permanent pacemaker (PM) in use or implantable cardioverter defibrillator (ICD)
- Patient cannot be prescribed non-vitamin K oral anticoagulant (NOAC)
- perform physical exercise for medical or personal reasons
- Exclusion criteria based on laboratory abnormalities
- Liver disease with increased plasma alanine aminotransferase (ALAT) levels of more than three times the upper limit of normal
- Renal dysfunction (eGFR \<30 ml/min), dialysis or kidney transplant
- Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, subjects may be enrolled, when thyroid function is controlled.
- HbA1c \>6.5% measured at screening
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04885634
Start Date
October 1 2022
End Date
November 1 2024
Last Update
November 3 2023
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