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

Phase 2

Completed

• Conditions: Acute Heart Failure
• Interventions: Drug: Dapagliflozin 10mg Tab; Other: Placebo

• Registration Number: NCT05406505
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-12
• Study Start: 2022-04-25
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-06
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozine 10mg	Dapagliflozin 10mg Tab	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in dyspnea ( Visual analogue scale) (VAS)	From baseline to day 4	• 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

Name	Time	Method
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	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	60 days from discharge	Difference in all cause mortality rate
Difference in serum levels of congestion biomarkers	4 days post-randomization	Difference in serum levels of Nt-ProBNP 4 days post-randomization
Hospital readmission	60 days from discharge	Difference between groups in rate of readmission after discharge for heart failure reason
Urinary sodium 2 hours post randomization	2 Hours	Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups

Trial Locations

Locations (1)

Noha Mansour; 🇪🇬 Mansoura, Egypt