Improving the Diagnosis and Treatment of Cardiovascular Diseases in Kazakhstan by Introducing Correction of Metabolism With Glucagon-like Peptide 1 (GLP-1) Drugs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in NT-proBNP levels from baseline to Week 24
研究概览
简要总结
This clinical study aims to improve the diagnosis and treatment of cardiovascular diseases in Kazakhstan by Implementing Metabolic Correction with Glucagon-Like Peptide-1 (GLP-1). These medicines are called incretin-based therapies and include GLP-1 receptor agonists and a newer dual therapy that targets both GIP and GLP-1 receptors. Such medications have already shown benefits in lowering blood sugar, reducing body weight, improving blood pressure, and lowering the risk of serious heart complications.
Cardiovascular diseases and diabetes are among the most common health problems in Kazakhstan. Many patients remain undiagnosed or receive treatment only after their condition becomes severe. This study seeks to address these challenges by testing how well dual incretin therapy works in improving heart health, blood sugar control, and overall metabolic status in adults who have both chronic heart failure and type 2 diabetes.
Participants in the study will receive a detailed health evaluation at the beginning, including heart tests, blood work, and genomic profiling. Genomic testing will help researchers understand whether certain genetic features affect how patients respond to this therapy. After the initial assessment, participants will start treatment with a GIP/GLP-1 receptor agonist and will be monitored every few months for a total of 40 weeks. During these visits, their heart function, blood sugar levels, weight, and other health indicators will be checked to ensure both safety and effectiveness.
The main hypothesis of the study is that dual incretin therapy will improve heart function, reduce cardiometabolic risks, and show measurable benefits in patients with both chronic heart failure and type 2 diabetes. The study also assumes that a person's genetic profile may influence how well they respond to treatment.
By the end of the project, researchers hope to better understand how these medications work in the Kazakhstani population and to use these findings to support more personalized, effective, and modern approaches to treating cardiovascular diseases.
详细描述
Title: Improving the Diagnosis and Treatment of Cardiovascular Diseases in Kazakhstan by Implementing Metabolic Correction with Glucagon-Like Peptide-1 (GLP-1).
Overview:
Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide and in Kazakhstan. The increasing prevalence of chronic conditions such as heart failure with preserved ejection fraction (HFpEF), obesity, and type 2 diabetes mellitus (T2DM) underscores the urgent need for integrated therapeutic approaches targeting both metabolic and cardiovascular risk factors. Despite advances in pharmacological and interventional care, standard therapies often fail to address underlying metabolic dysfunction and systemic inflammation, which are critical drivers of CVD progression.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual incretin receptor agonists such as tirzepatide represent a novel class of therapeutics with multimodal actions. These agents improve glycemic control, promote weight loss, modulate lipid metabolism, and exert direct cardiovascular protective effects, including endothelial stabilization, reduction of oxidative stress, attenuation of systemic inflammation, and modulation of myocardial remodeling.
This study aims to improving the Diagnosis and Treatment of Cardiovascular Diseases in Kazakhstan by Implementing Metabolic Correction with Glucagon-Like Peptide-1 (GLP-1) therapies. Integration of genomic profiling seeks to identify genetic determinants of therapeutic response, enabling a precision medicine approach and supporting the development of population-specific treatment guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure with preserved ejection fraction (left ventricular ejection fraction not ≤ 45%)
- •Type 2 diabetes mellitus (T2DM) with HbA1c level between ≥7.0% and ≤10.5%
- •Ongoing treatment for T2DM (e.g., metformin and/or sulfonylureas, or basal insulin therapy)
- •Stable body weight (±5%) for at least 3 months prior to screening
- •Body mass index (BMI) ≥ 25 kg/m²
- •Possible inclusion of patients with chronic pancreatitis in remission
- •Aged 18 years or older, and not older than 75 years
- •Both male and female participants
排除标准
- •Type 1 diabetes mellitus
- •Exacerbation of chronic pancreatitis
- •Acute pancreatitis
- •Proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy
- •History of bariatric (weight-loss) surgery or conditions associated with delayed gastric emptying
- •Acute or chronic hepatitis
- •Chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m²
- •Myocardial infarction or stroke within the past 2 months
- •Medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) in the participant or a first-degree relative
- •Use of any other antidiabetic medications (except metformin and/or sulfonylureas and basal insulin) within the past 3 months
- •Use of weight loss medications, including over-the-counter drugs, within the past 3 months
- •History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorders within the past 2 years
- •Healthy individuals (no cardiovascular or metabolic disease)
研究组 & 干预措施
Patients with heart failure and preserved ejection fraction (EF ≥ 45%)
Participants diagnosed with chronic heart failure with preserved ejection fraction (EF ≥ 45%) who receive treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
干预措施: dapagliflozin, empagliflozin, metformin (Drug)
Patients with heart failure and preserved ejection fraction (EF ≥ 45%)
Participants diagnosed with chronic heart failure with preserved ejection fraction (EF ≥ 45%) who receive treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
干预措施: Tirzepatide (Mounjaro) (Drug)
Patients with chronic heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes
Participants diagnosed with heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes mellitus who receive treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
干预措施: Tirzepatide (Mounjaro) (Drug)
Patients with chronic heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes
Participants diagnosed with heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes mellitus who receive treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
干预措施: dapagliflozin, empagliflozin, metformin (Drug)
结局指标
主要结局
Change in NT-proBNP levels from baseline to Week 24
时间窗: Baseline to Week 24
N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a biomarker of heart failure severity. A reduction in NT-proBNP reflects improved cardiac function. This outcome assesses the effect of tirzepatide on heart failure status.
次要结局
- Changes in metabolic associated with type 2 diabetes mellitus(Baseline to Week 24)
- Changes clinical parameters associated with heart failure(Baseline to Week 32)
- Changes in clinical parameters associated with heart failure and type 2 diabetes mellitus(Baseline to Week 24)
- Assessment of the Overall Condition of Patients Before and After the Study(Baseline to Week 40)