The Influence of Metformin on Chronic Heart Failure Clinical Course in Patients With Prediabetes

NCT04549415 | Completed Phase 4 DMC

• 1 other identifier: NoruzbaevaCHF
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known fact, that prediabetes is a predictor of high cardiovascular mortality, increasing the risk of developing such adverse cardiovascular events as myocardial infarction, stroke and sudden cardiac death. The key pathogenetic link in development of carbohydrates metabolism disorders (CMD) is insulin resistance (IR), which is one of the crucial mechanisms for the development and progression of chronic heart failure (CHF). IR disrupts the functioning of the myocardium due to endothelial dysfunction, inflammation, oxidative stress, remodeling and impaired myocardial metabolism. In condition of a combination of CMD and CHF the reverse development of hyperglycemia is also difficult due to hyperactivation of neurohormonal systems - renin-angiotensin-aldosterone system, in particular. So, drug therapy should neutralize the undesirable metabolic effects of hyperglycemia on the course of CHF, as well as prevent the development of micro- and macrovascular complications. The study will investigate the ability of metformin to impact on clinical and laboratory (neurohormonal, lipid profiles, renal function) parameters of ischemic etiology heart failure patients with prediabetes, as well as their quality of life and prognosis (incidence of adverse cardiovascular events). These tests will be assessed at the beginning and repeated after one year. At the end of the study we will investigate the difference between lifestyle modification effect and metformin treatment. The study is funded by Ministry of Education and Science of Kyrgyz Republic.

Conditions

Chronic Heart Failure; Coronary Artery Disease; PreDiabetes

Keywords

metformin; chronic heart failure; prediabetes; insulin resistance; clinical course

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

  Safety and efficacy of Metformin will be determined by monitoring changes from randomization till the end of the study or so long the patient remains in the study , whichever is earlier

  12 months

• Number of participants with newly diagnosed diabetes mellitus

  Carbohydrate metabolism indicators will be determined by monitoring changes in fasting, postprandial glycemia and glycated hemoglobin

  12 months

Secondary Outcomes (7)

• Chronic heart failure patients Quality of Life

  12 months

• 6-minute walking test results

  12 months

• Insulin resistance by HOMA-IR

  12 months

• Aldosterone levels

  12 months

• Nt-proBNP levels

  12 months

Study Arms (2)

metformin

ACTIVE COMPARATOR

Metformin, 1000 mg b.i.d, 12 months

Drug: Metformin Hydrochloride

lifestyle modification

ACTIVE COMPARATOR

Lifestyle modification Standard Principles

Other: lifestyle modification

Interventions

Metformin Hydrochloride DRUG

patients were divided into 2 groups: 1st group was on lifestyle modification (LSM), 2nd group on regimen "LSM+ metformin (1000 g b.i.d)" during 12 months

metformin

lifestyle modification OTHER

Lifestyle modification Standard Principles

lifestyle modification

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or over (not older 65 y.o)
• Participant willing and able to give informed consent
• Documented Coronary artery disease (CAD): either angio-graphically documented CAD or a previous history of myocardial infarction/angina.
• Verified heart failure functional class III (Nt-proBNP levels, 6-min walking test)
• Fasting insulin resistance ≥ 2.5 (HOMA-IR)
• Receiving basic therapy for CAD and chronic heart failure (CHF)
• Able (in the investigators opinion) and willing to comply with all study requirements

You may not qualify if:

• Cognitive impairments
• Type 1 or 2 Diabetes mellitus, antihyperglycemic therapy in anamnesis
• Unstable course of CAD
• Acute heart failure or CHF decompensation
• Malignancy (receiving active treatment) or other life threatening disease
• Renal dysfunction (stage 3B or worse)
• Thyroid dysfunction
• Pregnancy/lactating females
• Any other reason considered inappropriate by a study physician
• Participants who have participated in any other clinical trial within the previous 30 days

Sponsors & Collaborators

• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: lead

Study Sites (1)

National Centre of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Bishkek, 720001, Kyrgyzstan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Prediabetic State; Insulin Resistance; Disease Progression

Interventions

Metformin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Akbay Sarybaev

  National Centre of Cardiology and Internal Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, researcher in chronic heart failure department

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: January 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 15, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

KY (1)