Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to 70 Years; excludes diabetes; no BMI minimum stated; conditions: Obesity & Overweight; Adult Congenital Heart Disease
- Interventions
- Treatment with tirzapatide; Treatment with placebo
- Conditions
- Obesity & Overweight; Adult Congenital Heart Disease
- Phase and size
- Phase 4 · 30 participants
- Dates
- Start 2026-01-20
Primary completion 2027-06-30 - Sponsor
- University Medical Centre Ljubljana (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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).
- 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).
- 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).
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.