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Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)

Primary Purpose

Acute Heart Failure

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Dapagliflozin 10mg Tab

Placebo

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Diabetic and non diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound.
OR
*If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.
Randomized within 24 hours of hospitalization for AHF
Planned use of IV loop diuretic therapy during current hospitalization
Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation
For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.

Exclusion Criteria:

Type 1 diabetes mellitus.
Dyspnea primarily due to non-cardiac causes.
Cardiogenic shock.
Acute coronary syndrome within 30 days prior to randomization.
Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L).
Pregnant or nursing (lactating) women.
Heart failure due to drug toxicity
Adherence to medication less than 95%

Sites / Locations

Noha Mansour

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozine 10mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in dyspnea ( Visual analogue scale) (VAS)

• Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups

Secondary Outcome Measures

Incidence of worsening heart failure (HF)

Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support.

All-cause death

Difference in all cause mortality rate

All-cause death

Difference in all cause mortality rate

Hospital readmission

Difference between groups in rate of readmission after discharge for heart failure related reason

Hospital readmission

Difference between groups in rate of readmission after discharge for heart failure reason

Urinary sodium 2 hours post randomization

Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups

Difference in serum levels of congestion biomarkers

Difference in serum levels of Nt-ProBNP 4 days post-randomization

Full Information

NCT ID

NCT05406505

First Posted

November 12, 2021

Last Updated

August 1, 2023

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05406505

Brief Title

Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)

Official Title

Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 25, 2022 (Actual)

Primary Completion Date

May 1, 2023 (Actual)

Study Completion Date

July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

Keywords

Diabetic and non diabetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapagliflozine 10mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin 10mg Tab

Intervention Description

patients will receive once daily dapagliflozin 10 mg orally in addition to standard care

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

patients will receive placebo and standard care.

Primary Outcome Measure Information:

Title

Change in dyspnea ( Visual analogue scale) (VAS)

Description

Time Frame

From baseline to day 4

Secondary Outcome Measure Information:

Title

Incidence of worsening heart failure (HF)

Description

Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support.

Time Frame

From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days

Title

All-cause death

Description

Difference in all cause mortality rate

Time Frame

30 days from discharge

Title

All-cause death

Description

Difference in all cause mortality rate

Time Frame

60 days from discharge

Title

Hospital readmission

Description

Difference between groups in rate of readmission after discharge for heart failure related reason

Time Frame

30 days from discharge

Title

Hospital readmission

Description

Difference between groups in rate of readmission after discharge for heart failure reason

Time Frame

60 days from discharge

Title

Urinary sodium 2 hours post randomization

Description

Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups

Time Frame

2 Hours

Title

Difference in serum levels of congestion biomarkers

Description

Difference in serum levels of Nt-ProBNP 4 days post-randomization

Time Frame

4 days post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either: * 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR *If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above. Randomized within 24 hours of hospitalization for AHF Planned use of IV loop diuretic therapy during current hospitalization Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission. Exclusion Criteria: Type 1 diabetes mellitus. Dyspnea primarily due to non-cardiac causes. Cardiogenic shock. Acute coronary syndrome within 30 days prior to randomization. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L). Pregnant or nursing (lactating) women. Heart failure due to drug toxicity Adherence to medication less than 95%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noha Mansour, PhD

Organizational Affiliation

Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Moheb Magdy Mouris, MD

Organizational Affiliation

Department of Cardiology, Faculty of Medicine, University of Mansoura

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed El-Husseiny Shams, Proffesor

Organizational Affiliation

Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Official's Role

Study Chair

Facility Information:

Facility Name

Noha Mansour

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

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Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)

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