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

February 15, 2022 updated by: Mohamed Abdelfatah, Assiut University

Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Inclusion Criteria:

Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified inclusion criterion with respect to heart failure etiology and/or ejection fraction.

Age more than 18 years Admission for acute decompensated heart failure The patient already on an oral loop diuretic for at least 1 month before admission, at a dose between 40 mg and 80 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of Torsemide will be considered to be equivalent to 40 mg of furosemide.

Exclusion Criteria:

  1. Other etiologies of fluid overload different from heart failure.
  2. Hyponatremia: Sodium level below 125mmol/l
  3. Unstable patients: acute coronary syndrome, cardiogenic shock .
  4. Patients requiring inotropic agents or renal dialysis.
  5. Pregnancy or breastfeeding period.
  6. sever hepatic disease
  7. GFR (Glomerular Filtration Rate) is less than 45 mL/min/1.73 m² .
  8. Patient with diabetic ketoacidosis or non ketotic hyperosmolar. Treatment arm.

The patients will receive:

Loop diuretics. Diuretics should be administered at doses sufficient to achieve optimal volume status and relieve congestion without inducing an excessively rapid reduction in intravascular volume.

furosemide will be given I.V either by continuous infusion or blouses Antifailure treatment: (Angiotensin converting enzyme inhibitors or Angiotensin II Receptor Blockers, Beta Blockers,Mineralocorticoid Receptor Antagonists, Ivabradine, or others will be individualized according to the patient condition.

Dapagliflozin:

will be given in a dose of 10mg once daily ( GFR is more than 45 mL/min/1.73 m²) .

In Mild or moderate hepatic disease: No dosage adjustment required In Severe hepatic disease: will not be used.

Insulin. Insulin therapy should be initiated if blood glucose levels is ≥180 mg/dL (10.0 mmol/L) after initiation of Dapagliflozin treatment. Once insulin therapy is started, a target glucose range of 140-180 mg/dL (7.8-10.0 mmol/L) is recommended The use of subcutaneous rapid- or short-acting insulin before meals or every 4-6 h will be given to correct hyperglycemia according to sliding scale chart.

Control arm.

The patients will be given Loop diuretics. Anti-failure treatment. Insulin.

All the patients will undergo:

  1. Complete echo assessment.
  2. ECG on admission and daily.
  3. Monitoring:24 hours ECG ,Oxygen saturation and blood pressure monitoring. Complete blood count ,blood urea,serum creatinine,blood sugar,electrolytes ,liver function will be measured on admission
  4. Blood sugar ,urea,creatinine,Na, K will be measured daily along the whole days of admission.

Follow up parameters

Diuresis :24-hour diuresis will be quantified every 24 hours (during hospitalization) from the 1st day until last day of admission.

diuretic response will be measured by weight loss and net fluid loss per mg . Changes in body weight measurements: the mean of weight lost every 24 hours and the total weight lost from baseline to the last day of hospitalization Renal function will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.

Renal function is assessed with the serum creatinine level. Worsening renal function is defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time during hospitalization Electrolyte levels (sodium and potassium) will be determined every 24 hours (during hospitalization) from the date of admission until the date of discharge.

Electrolyte levels are assessed with the serum sodium and potassium levels. Patient-reported dyspnea : Patient-reported dyspnea is assessed every 24 hours (during hospitalization) from the date of admission until the date of discharge.

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuan, Egypt, 71515
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dapagliflozin group
50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.
Drug: Dapagliflozin
Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.
Other Names:
  • SGLT-2 inhibitors
Drug: insulin
insulin
Placebo Comparator: Placebo group
50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
Drug: insulin
insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body weight measurement (Diuresis effect.)
Time Frame: Days of admission (3-5 days)
Diuretic response will be measured by weight loss
Days of admission (3-5 days)
Diuresis effect.
Time Frame: Days of admission (3-5 days)
Diuretic response will be measured by net fluid loss per mg .
Days of admission (3-5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: Days of admission (3-5 days)
Renal function is assessed with the serum creatinine level. Worsening renal function is defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time during hospitalization
Days of admission (3-5 days)
Patient-reported dyspnea will be assessed with the use five point Linker scale
Time Frame: Days of admission (3-5 days)
Days of admission (3-5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ayman Ibrahem, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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