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NCT04549415
The Influence of Metformin on Chronic Heart Failure Clinical Course in Patients With Prediabetes
Phase 4 trial testing Metformin Hydrochloride in Chronic Heart Failure in 97 participants. Completed in 15 November 2019.
1 November 2018
Quick facts
| Lead sponsor | National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 1 January 2018 |
| Primary completion | 1 November 2018 |
| Estimated completion | 15 November 2019 |
| Sites | 1 location across Kyrgyzstan |
Drugs / interventions tested
- Metformin Hydrochloride — full drug profile →
- lifestyle modification
Conditions studied
- Chronic Heart Failure — all drugs for Chronic Heart Failure →
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- PreDiabetes — all drugs for PreDiabetes →
Sponsor
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Who can join
Adults 18 to 65, any sex, with Chronic Heart Failure or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Other recruiting trials for Chronic Heart Failure
Currently open trials in the same condition.
- NCT07265349 — A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure · Phase 1, PHASE2 · recruiting
- NCT07379840 — A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South K · recruiting
- NCT07325942 — Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure · NA · recruiting
- NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
- NCT07405944 — Vericiguat and Reverse Remodeling Indices in Heart Failure · Phase 4 · recruiting
Other National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov trials
Trials by the same sponsor.
- NCT04591964 — Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application · EARLY_PHASE1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04549415 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Last refreshed: 16 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04549415.
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