Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
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.
详细描述
Introduction Obesity is a complex multifactorial disease with major impact on the cardiovascular system and subsequent adverse cardiovascular events.
Congenital heart disease (CHD) is the most common congenital disease. With the advancement of the treatment nowadays around 90% of patients with mild, 75% with moderate, and 40% with complex congenital heart disease reach the age of 60 years. With aging, acquired heart disease is becoming more prevalent and poses a growing concern in adults with CHD (ACHD). The ACHD patients are at an increased risk for atherosclerotic cardiovascular disease and its risk factors. In comparison to the general population, patients with ACHD have more severe risk factors for atherosclerosis, which frequently clinically presents at an earlier age and has increased morbidity and mortality.
Among well known risk factors for atherosclerotic cardiovascular disease, obesity plays an important role. It is estimated that, similarly to general population, up to 40-50% of ACHD patients are overweight or obese. These patients are at an increased risk for arterial hypertension, hyperlipidaemia, and diabetes. The development of obesity in ACHD is multifactorial, potentially including inadequate education on healthy lifestyle, sedentary lifestyle, and overfeeding during infancy.
CHD is a long-life disease, requiring frequent interventions throughout life, among them also surgical and catheter interventions. Obesity poses a risk for complications in surgical and catheter interventions, which increase morbidity and mortality in these patients.
Novel pharmacological treatment of obesity is an emerging help in reducing not only weight in obese patients but also contributing to diminishing obesity-related adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究者
Katja Prokselj
Assoc. prof., senior consultant
University Medical Centre Ljubljana