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.
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%)
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
Parallel
Treatment with tirzapatide
DrugTreatment 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
DrugTreatment 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.
Change in exercise capacity after 6 months of treatment with tirzepatide.
• 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.
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.
Patient's blood will be drawn between 8 and 9 am, after fasting. Cholesterol concentration will be expressed as mmol/L.
Change in endothelial function after 6 months of treatment with tirzepatide.
Endothelial function will be measured by endothelium-dependent vasodilation, expressed in %.
Change in arterial stiffness after 6 months of treatment with tirzepatide.
Arterial stiffness ill be evaluated by pulse wave velocity, expressed in m/s.
Change in body weight after 6 months of treatment with tirzepatide.
Body weight will be measured in kilograms.
Change of quality of life after 6 months of treatment with tirzepatide.
Quality of life will be evaluated by 36-Item Short Form Survey questionnaire and expressed on a scale scores, ranging from 0 to 100 (lower values representing worse outcome).
Change of anxiety and depression after 6 months of treatment with tirzepatide.
Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale questionnaire and expressed on a scale scores, ranging from 0 to 21 (lower values representing better outcome).
Change of physical activity after 6 months of treatment with tirzepatide.
Physical activity will be evaluated by International Physical Activity questionnaire and expressed in MET-minutes/week.
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