Opening soonPhase 4Interventional
What this study is about
Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD. In a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight, Adult Congenital Heart Disease
Full registry criteria
Inclusion Criteria: * Obese or overweight adult patients with congenital heart disease * BMI between 30 kg/m² and 40 kg/m² * Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5% * Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%) * No prior pharmacological or surgical interventions for obesity * Euthyroid state * Eumenorrhea or oligomenorrhea * Ability to comprehend the study objectives and procedures * Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate * Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment. Exclusion Criteria: * Down syndrome * Type 2 diabetes * Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle \< 30%, malignant arrhythmias, severe heart valve disease * Personal history of malignancy, personal or family history of medullary thyroid carcinoma * Personal history of pancreatitis or cholelithiasis * Personal history of acute coronary events or hemodynamically significant coronary artery disease * Current treatment with sympathomimetics or sympatholytic * Psychiatric disorders, personal history of depressive disorders or suicidal ideation * Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods * Excessive alcohol consumption * Smoking
Treatments and study arms
Treatment with tirzapatide
Drug
Treatment with tirzepatide for 6 months, starting dosage 2,5 mg subcutaneous. Titration every 4 weeks by 2,5 mg increase, based on clinical response and tolerability of adverse effects, up to a maximum dose of 15 mg.
Treatment with placebo
Drug
Treatment with palcebo for 6 months, 0.9% saline via administrated via identical pens subcutaneous once weekly, same as active comparator, according to the same study protocol.
Primary outcomes
Change in exercise capacity after 6 months of treatment with tirzepatide.From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).• Exercise capacity will be measured by maximum oxygen consumption at cardiopulmonary exercise testing, expressed in mL/kg/min.
Change in left ventricular systolic function after 6 months of treatment with tirzepatide.From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).Left ventricular systolic function will be evaluated echocardiographically by global longuitudinal strain (GLS), expressed in %
Change in cholesterol levels after 6 months of treatment with tirzepatide.From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).Patient's blood will be drawn between 8 and 9 am, after fasting. Cholesterol concentration will be expressed as mmol/L.
Study locations
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No public site location was included in this record. Check the original registry for updates.
