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

Sponsor
Nazarbayev University
Study ID
NCT07303556
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 18, 2024
Status verified
Jan 2026
Primary completion
Jul 1, 2025
Completion
Nov 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Change in NT-proBNP levels from baseline to Week 24 [ Time Frame: Baseline to Week 24 ]

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