Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure

NCT04385589 | Completed Phase 4 DMC

• 1 other identifier: 3241
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Changes in body weight measurement (Diuresis effect.)

  Diuretic response will be measured by weight loss

  Days of admission (3-5 days)

• Diuresis effect.

  Diuretic response will be measured by net fluid loss per mg .

  Days of admission (3-5 days)

Secondary Outcomes (2)

• Renal function

  Days of admission (3-5 days)

• Patient-reported dyspnea will be assessed with the use five point Linker scale

  Days of admission (3-5 days)

Study Arms (2)

Dapagliflozin group

ACTIVE COMPARATOR

50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.

Drug: Dapagliflozin; Drug: insulin

Placebo group

PLACEBO COMPARATOR

50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures.

Drug: insulin

Interventions

Dapagliflozin DRUG

Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.

Also known as: SGLT-2 inhibitors

Dapagliflozin group

insulin DRUG

insulin

Dapagliflozin group; Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Other etiologies of fluid overload different from heart failure.
• Hyponatremia: Sodium level below 125mmol/l
• Unstable patients: acute coronary syndrome, cardiogenic shock .
• Patients requiring inotropic agents or renal dialysis.
• Pregnancy or breastfeeding period.
• sever hepatic disease
• GFR is less than 45 mL/min/1.73 m² .
• Patient with diabetic ketoacidosis or non ketotic hyperosmolar.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Aswān, 71515, Egypt

Location

Related Publications (6)

• Ohara K, Masuda T, Morinari M, Okada M, Miki A, Nakagawa S, Murakami T, Oka K, Asakura M, Miyazawa Y, Maeshima A, Akimoto T, Saito O, Nagata D. The extracellular volume status predicts body fluid response to SGLT2 inhibitor dapagliflozin in diabetic kidney disease. Diabetol Metab Syndr. 2020 May 1;12:37. doi: 10.1186/s13098-020-00545-z. eCollection 2020.

  PMID: 32377235 BACKGROUND

• Elsisi GH, Anwar MM, Khattab M, Elebrashy I, Wafa A, Elhadad H, Awad M, Carapinha JL. Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt. J Med Econ. 2020 Aug;23(8):908-914. doi: 10.1080/13696998.2020.1764571. Epub 2020 May 28.

  PMID: 32364032 BACKGROUND

• Linden K, Mailey J, Kearney A, Menown IBA. Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials. Adv Ther. 2020 Jun;37(6):2620-2645. doi: 10.1007/s12325-020-01355-5. Epub 2020 May 2.

  PMID: 32361851 BACKGROUND

• Cappetta D, De Angelis A, Ciuffreda LP, Coppini R, Cozzolino A, Micciche A, Dell'Aversana C, D'Amario D, Cianflone E, Scavone C, Santini L, Palandri C, Naviglio S, Crea F, Rota M, Altucci L, Rossi F, Capuano A, Urbanek K, Berrino L. Amelioration of diastolic dysfunction by dapagliflozin in a non-diabetic model involves coronary endothelium. Pharmacol Res. 2020 Jul;157:104781. doi: 10.1016/j.phrs.2020.104781. Epub 2020 Apr 28.

  PMID: 32360273 BACKGROUND

• Kasem SM, Saied GM, Hegazy ANM, Abdelsabour M. Impact of Acute Insulin Resistance on Myocardial Blush in Non-Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention. Front Cardiovasc Med. 2021 May 10;8:647366. doi: 10.3389/fcvm.2021.647366. eCollection 2021.

  PMID: 34041280 DERIVED

• Ibrahim A, Ghaleb R, Mansour H, Hanafy A, Mahmoud NM, Abdelfatah Elsharef M, Kamal Salama M, Elsaughier SM, Abdel-Wahid L, Embarek Mohamed M, Ibrahim AK, Abdel-Galeel A. Safety and Efficacy of Adding Dapagliflozin to Furosemide in Type 2 Diabetic Patients With Decompensated Heart Failure and Reduced Ejection Fraction. Front Cardiovasc Med. 2020 Dec 7;7:602251. doi: 10.3389/fcvm.2020.602251. eCollection 2020.

  PMID: 33426003 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Insulin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ayman Ibrahem, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: May 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 20, 2020
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)