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

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406505
• Other study ID #: 2022-61
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 25, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Dapagliflozin 10mg Tab
patients will receive once daily dapagliflozin 10 mg orally in addition to standard care

Other:
• Placebo
patients will receive placebo and standard care.

Locations

Country	Name	City	State
Egypt	Noha Mansour	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days
Secondary	All-cause death	Difference in all cause mortality rate	30 days from discharge
Secondary	All-cause death	Difference in all cause mortality rate	60 days from discharge
Secondary	Hospital readmission	Difference between groups in rate of readmission after discharge for heart failure related reason	30 days from discharge
Secondary	Hospital readmission	Difference between groups in rate of readmission after discharge for heart failure reason	60 days from discharge
Secondary	Urinary sodium 2 hours post randomization	Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups	2 Hours
Secondary	Difference in serum levels of congestion biomarkers	Difference in serum levels of Nt-ProBNP 4 days post-randomization	4 days post-randomization