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Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs (ICDDTKZ26) 120 Personalisiert

Aktiv, nicht rekrutierend
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Die klinische Studie NCT07303556 (ICDDTKZ26) ist eine interventionsstudie zur Untersuchung von Herzinsuffizienz, Diabetes Typ 2, Arterielle Hypertonie und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 18. Dezember 2024 und soll 120 Teilnehmer aufnehmen. Durchgeführt von Nazarbayev University ist der Abschluss für 1. November 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 28. Januar 2026 aktualisiert.
Kurzbeschreibung
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 ...Mehr anzeigen
Ausführliche Beschreibung
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 dia...

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Offizieller Titel

Improving the Diagnosis and Treatment of Cardiovascular Diseases in Kazakhstan by Introducing Correction of Metabolism With Glucagon-like Peptide 1 (GLP-1) Drugs

Erkrankungen
HerzinsuffizienzDiabetes Typ 2Arterielle Hypertonie
Weitere Studien-IDs
  • ICDDTKZ26
  • BR24993023
NCT-Nummer
NCT07303556
Studienbeginn (tatsächlich)
2024-12-18
Zuletzt aktualisiert
2026-01-28
Studienende (vorauss.)
2026-11-01
Geplante Rekrutierung
120
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
Heart Failure
Diabete Type 2
Preserved Ejection Fraction
Sequencing
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellPatients 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
Tirzepatide (Mounjaro)
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
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.
ExperimentellPatients 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
Tirzepatide (Mounjaro)
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
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Changes in clinical parameters associated with heart failure and type 2 diabetes mellitus
Change in body weight (kg)
Baseline to Week 24
Changes in metabolic associated with type 2 diabetes mellitus
Change in HbA1c (%)
Baseline to Week 24
Assessment of the Overall Condition of Patients Before and After the Study
\- Changes in clinical parameters associated with heart failure, including quality-of-life assessment using the SF-36 questionnaire for general physical and mental health and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) for heart failure-specific quality of life. This parameter will be assessed individually, twice during the study period: at baseline and at the end at week 40 of the study, to assess the overall metabolic and cardiac impact of tirzepatide in patients with heart failure with preserved ejection fraction and type 2 diabetes mellitus.
Baseline to Week 40
Changes clinical parameters associated with heart failure
-Change in left ventricular ejection fraction (LVEF) by echocardiography
Baseline to Week 32
Changes in clinical parameters associated with heart failure and type 2 diabetes mellitus
Height parameters (cm)
Baseline to Week 24
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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

  • 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)
Nazarbayev University logoNazarbayev University
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1 Studienstandorte in 1 Ländern

Kazakhstan

PI "National Laboratory Astana", Nazarbayev University, Astana, Kazakhstan, 010000, Kazakhstan