The Effect of Addition of Metformin to SGLT2 In Diabetic Patients With Heart Failure With Preserved Ejection Fraction

NCT06080802 | Unknown Phase 2 DMC

• 1 other identifier: C1/HEC1/2023PD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

a prospective open-label, randomized controlled study to evaluate the efficacy of the addition of metformin to SGLT2 in diabetic patient with preserved ejection fraction

Conditions

Heart Failure With Preserved Ejection Fraction; Diabete Type 2

Keywords

metformin; SGLTi; HFpEF

Outcome Measures

Primary Outcomes (2)

• Hospitalization rate

  Hospitalization rate

  baseline, 3 and 6 months

• HRQOL using Minnesota Living with Heart Failure Questionnaire for quality-of-life evaluation (MLFHQ)

  HRQOL using Minnesota Living with Heart Failure Questionnaire for quality-of-life evaluation (MLFHQ)

  baseline, 3 and 6 months

Secondary Outcomes (6)

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

  baseline, 3 and 6 months

• adverse drug effects

  baseline, 3 and 6 months

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

  baseline, 3 and 6 months

• Neutrophil/lymphocyte ratio -AMPK pathway

  baseline, 3 and 6 months

• Inflammatory and oxidative stress

  baseline, 3 and 6 months

Study Arms (2)

control(SGLT2i/ARBs/MRA/ +/- diuretics).

NO INTERVENTION

Lifestyle counseling plus standard evidence-based therapy for HFpEF (SGLT2i/ARBs/MRA/ +/- diuretics).

intervention

EXPERIMENTAL

Lifestyle counseling plus standard evidence-based therapy for HFpEF (SGLT2i/ARBs/MRA/ +/- diuretics)+ metformin

Drug: Metformin

Interventions

Metformin DRUG

The intervention will consist in giving metformin starting with 500 mg once daily 1 gm 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) during the rest of the follow-up. Patients will be followed up by telephone call 2 weeks intervals during the study period 5 SGL-2 will be prescribed to group 1 after diagnosis with HFpEF while group 2 will have SGL-2 and Metformin

intervention

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 I-IV. Diabetic patients SGL-2 naive. Newly diagnosed heart failure of preserved ejection fraction

You may not qualify if:

• Patients with heart failure with reduced ejection fraction (\< 40%) Age less than 40 and more than 74 GFR \< 30 mL/min A1c \> 9 Known allergy to metformin End- stage liver disease Cancer Pregnancy or lactation

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead
• clinical research unit, El-sheikh zayed specialized hospital - Egyptian Ministry of health: collaborator

Study Sites (1)

clinical research uint- El-sheikh zayed specialized hospital SMC- Egyptian Ministry of health

Cairo, Egypt

Location

Related Publications (2)

• ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.

  PMID: 36507650 BACKGROUND

• Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available.

  PMID: 37137593 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• sara M eladawy

  MSA university

  STUDY DIRECTOR

• Mai abdelhafez, PhD

  MSA university

  STUDY CHAIR

Central Study Contacts

sara M eladawy

CONTACT

01222124567; smeladway@msa.edu.eg

hassan abdellatif

CONTACT

01092990402; hassangamal79@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)