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

NCT07303556 | Active Not Recruiting DMC

• 1 other identifier: BR24993023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Diabete Type 2; Arterial Hypertension

Keywords

Heart Failure; Diabete Type 2; Preserved Ejection Fraction; Sequencing

Outcome Measures

Primary Outcomes (1)

• Change in NT-proBNP levels from 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.

  Baseline to Week 24

Secondary Outcomes (5)

• Changes in clinical parameters associated with heart failure and type 2 diabetes mellitus

  Baseline to Week 24

• Changes in metabolic associated with type 2 diabetes mellitus

  Baseline to Week 24

• Assessment of the Overall Condition of Patients Before and After the Study

  Baseline to Week 40

• 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

Study Arms (2)

Patients with heart failure and preserved ejection fraction (EF ≥ 45%)

EXPERIMENTAL

Participants diagnosed with chronic heart failure with preserved ejection fraction (EF ≥ 45%) who receive treatment with glucagon-like peptide-1 (GLP-1) receptor agonists

Drug: Tirzepatide (Mounjaro); Drug: dapagliflozin, empagliflozin, metformin

Patients with chronic heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes

EXPERIMENTAL

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

Drug: Tirzepatide (Mounjaro); Drug: dapagliflozin, empagliflozin, metformin

Interventions

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.

Also known as: Dual GIP/GLP-1 receptor agonist

Patients with chronic heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes; Patients with heart failure and preserved ejection fraction (EF ≥ 45%)

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.

Also known as: Forxiga, Jardiance, Siofor

Patients with chronic heart failure with preserved ejection fraction (EF ≥ 45%) and type 2 diabetes; Patients with heart failure and preserved ejection fraction (EF ≥ 45%)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Aged 18 years or older, and not older than 75 years
• Both male and female participants

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nazarbayev University: lead

Study Sites (1)

PI "National Laboratory Astana", Nazarbayev University

Astana, Kazakhstan, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2; Hypertension

Interventions

Tirzepatide; dapagliflozin; empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: December 26, 2025
• Study Start: December 18, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

KA (1)