Clinical trial NCT05406505: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Heart Failure
Keywords: Diabetic and non diabetic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Randomized within 24 hours of hospitalization for AHF
3. Planned use of IV loop diuretic therapy during current hospitalization
4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation
5. For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in dyspnea ( Visual analogue scale) (VAS)
timeFrame: From baseline to day 4
Secondary outcomes:
measure: Incidence of worsening heart failure (HF)
timeFrame: From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days
measure: All-cause death
timeFrame: 30 days from discharge
measure: All-cause death
timeFrame: 60 days from discharge
measure: Hospital readmission
timeFrame: 30 days from discharge
measure: Hospital readmission
timeFrame: 60 days from discharge
measure: Urinary sodium 2 hours post randomization
timeFrame: 2 Hours
measure: Difference in serum levels of congestion biomarkers
timeFrame: 4 days post-randomization
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Noha Mansour
Study officials:
affiliation: Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
name: Noha Mansour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Faculty of Medicine, University of Mansoura
name: Moheb Magdy Mouris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
name: Mohamed El-Husseiny Shams, Proffesor
role: STUDY_CHAIR
References: