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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dapagliflozine 10mg

Group Type EXPERIMENTAL

Dapagliflozin 10mg Tab

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

patients will receive placebo and standard care.

Interventions

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Dapagliflozin 10mg Tab

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

Intervention Type DRUG

Placebo

patients will receive placebo and standard care.

Intervention Type OTHER

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No