Clinical trial

Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07303556

Active, not recruitingNot applicableInterventional

What this study is about

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.

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 75 Years

SexAll

Healthy volunteersNot accepted

ConditionHeart Failure, Diabete Type 2, Arterial Hypertension

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Treatments and study arms

Tirzepatide (Mounjaro)

Drug

Tirzepatide is a dual GIP and GLP-1 receptor agonist administered by subcutaneous injection once weekly. It is used to improve cardiac function and metabolic control in patients with chronic heart failure with preserved ejection fraction. Dosage and treatment duration are defined by the study protocol.

dapagliflozin, empagliflozin, metformin

Drug

Standard treatment according to current clinical guidelines for chronic heart failure, which may include ACE inhibitors, beta-blockers, diuretics, insulin or oral hypoglycemics as appropriate.

Primary outcomes

Change in NT-proBNP levels from baseline to Week 24Baseline 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

PI "National Laboratory Astana", Nazarbayev University🌐 Astana, Kazakhstan, Kazakhstan

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