The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction

NCT05847244 | Unknown Phase 2 DMC

• 1 other identifier: RSPL1.5
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Diabetes mellitus people have a higher incidence of cardiovascular disease, and the results of cardiovascular events are worse. Heart failure and diabetes both have a worse prognosis, with a 1.5-2 times increased risk of death. Data from the literature have shown that MET lowers mortality by 14-35% in this patient population, which represents one-third of all HF patients with no increases in lactic acidosis incidence.

Conditions

Diastolic Dysfunction; Obesity

Keywords

metformin; obesity; diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• The change in the mean early diastolic mitral annular velocity (mean e'), at 3 and 6 months

  Mean early diastolic mitral annular velocity assessed by echocardiography

  baseline, 3 and 6 months

Secondary Outcomes (5)

• HRQOL (MLFHQ) adverse effects of metformin hospitalization rate Change in N-terminal pro-BNP (NT-proBNP) and Change in body weight

  baseline, 3 and 6 months

• adverse effects of metformin

  baseline, 3 and 6 months

• hospitalization rate

  baseline, 3 and 6 months

• Change in N-terminal pro-BNP (NT-proBNP)

  baseline, 3 and 6 months

• Change in body weight

  baseline, 3 and 6 months

Study Arms (2)

control

NO INTERVENTION

Lifestyle counseling plus standard evidence based therapy

intervention (metformin)

EXPERIMENTAL

Lifestyle counseling plus standard evidence based therapy and metformin (target dose 1000 mg bid)

Drug: Metformin

Interventions

Metformin DRUG

The intervention will consist in giving metformin starting with 500 mg once daily (at breakfast) during the first week; if well tolerated, the dose was progressively increased to 500 mg twice daily (at breakfast and dinner) during week 2, to 1000 mg at breakfast and 500 mg at dinner during week 3, in order to reach the target dose of 1000 mg twice daily (at breakfast and dinner)

intervention (metformin)

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 40 years to 74 years.
• HFpEF (≥ 50%)
• Written informed consent of the subject to participate in the study.
• New York Heart Association functional class II-IV.
• Body mass index ≥ 30 Kg/m2

You may not qualify if:

• Patients with heart failure with reduced ejection fraction (\< 40%)
• Age less than 40 and more than 74
• New York Heart Association functional class I
• Body mass index \< 30 Kg/m2
• Diabetic patients or prior metformin user
• Renal impairment
• Known allergy to metformin
• End- stage liver disease
• Cancer
• Pregnancy or lactation

Sponsors & Collaborators

• Sara ElAdawy: lead
• Cairo University: collaborator

Study Sites (2)

Cairo University Hospitala

Cairo, Egypt

RECRUITING

Cairo University Hospitals

Cairo, Egypt

NOT YET RECRUITING

Related Publications (4)

• Pu R, Shi D, Gan T, Ren X, Ba Y, Huo Y, Bai Y, Zheng T, Cheng N. Effects of metformin in obesity treatment in different populations: a meta-analysis. Ther Adv Endocrinol Metab. 2020 May 21;11:2042018820926000. doi: 10.1177/2042018820926000. eCollection 2020.

  PMID: 32499908 RESULT

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.

  PMID: 24222017 RESULT

• Ladeiras-Lopes R, Sampaio F, Leite S, Santos-Ferreira D, Vilela E, Leite-Moreira A, Bettencourt N, Gama V, Braga P, Fontes-Carvalho R. Metformin in non-diabetic patients with metabolic syndrome and diastolic dysfunction: the MET-DIME randomized trial. Endocrine. 2021 Jun;72(3):699-710. doi: 10.1007/s12020-021-02687-0. Epub 2021 Apr 8.

  PMID: 33830437 RESULT

• Halabi A, Sen J, Huynh Q, Marwick TH. Metformin treatment in heart failure with preserved ejection fraction: a systematic review and meta-regression analysis. Cardiovasc Diabetol. 2020 Aug 5;19(1):124. doi: 10.1186/s12933-020-01100-w.

  PMID: 32758236 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• sara Eladawy, PhD

  MSa university

  STUDY DIRECTOR

• Naglaa Bazan, Ass. Prof

  Cairo University

  PRINCIPAL INVESTIGATOR

• shreen Elgengeehy, Prof.

  Cairo University

  STUDY CHAIR

Central Study Contacts

sara eladawy, PhD

CONTACT

01222124567; smeladway@msa.edu.eg

naglaa bazan, Ass.Prof

CONTACT

01005807504; naglaabazan@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of clinical pharmacy

Model Details: prospective open-label, randomized controlled study

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: May 6, 2023
• Study Start: October 1, 2023
• Primary Completion: October 10, 2024
• Study Completion: December 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)