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Completed

NCT Number: NCT05406505

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

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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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Noha Mansour

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • 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.

Exclusion criteria

  • 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%

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

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

Placebo

Other

patients will receive placebo and standard care.

Primary outcomes

  1. Change in dyspnea ( Visual analogue scale) (VAS)

    Time frame: 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 outcomes

  1. Incidence of worsening heart failure (HF)

    Time frame: 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.

  2. All-cause death

    Time frame: 30 days from discharge

    Difference in all cause mortality rate

  3. All-cause death

    Time frame: 60 days from discharge

    Difference in all cause mortality rate

  4. Hospital readmission

    Time frame: 30 days from discharge

    Difference between groups in rate of readmission after discharge for heart failure related reason

  5. Hospital readmission

    Time frame: 60 days from discharge

    Difference between groups in rate of readmission after discharge for heart failure reason

  6. Urinary sodium 2 hours post randomization

    Time frame: 2 Hours

    Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups

  7. Difference in serum levels of congestion biomarkers

    Time frame: 4 days post-randomization

    Difference in serum levels of Nt-ProBNP 4 days post-randomization

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2022
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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