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

NCT05406505 | Completed Phase 2

• 1 other identifier: 2022-61
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Keywords

Diabetic and non diabetic

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to day 4

Secondary Outcomes (7)

• Incidence of worsening heart failure (HF)

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

• All-cause death

  30 days from discharge

• All-cause death

  60 days from discharge

• Hospital readmission

  30 days from discharge

• Hospital readmission

  60 days from discharge

Study Arms (2)

Dapagliflozine 10mg

EXPERIMENTAL

Drug: Dapagliflozin 10mg Tab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

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

Dapagliflozine 10mg

Placebo OTHER

patients will receive placebo and standard care.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• \*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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Noha Mansour

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Emara AN, Wadie M, Mansour NO, Shams MEE. The clinical outcomes of dapagliflozin in patients with acute heart failure: A randomized controlled trial (DAPA-RESPONSE-AHF). Eur J Pharmacol. 2023 Dec 15;961:176179. doi: 10.1016/j.ejphar.2023.176179. Epub 2023 Nov 2.

  PMID: 37923161 DERIVED

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Noha Mansour, PhD

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

  PRINCIPAL INVESTIGATOR

• Moheb Magdy Mouris, MD

  Department of Cardiology, Faculty of Medicine, University of Mansoura

  PRINCIPAL INVESTIGATOR

• Mohamed El-Husseiny Shams, Proffesor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: June 6, 2022
• Study Start: April 25, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

EG (1)