Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction (CODA-HFrEF)

NCT06012279 | Completed Phase 4

• 1 other identifier: MD-343-2021
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the short-term clinical outcomes of starting Dapagliflozin on the same day of hospital admission in patients with acute decompensated heart failure (ADHF) with reduced ejection fraction. The main questions it aims to answer are:

• Does early initiation of Dapagliflozin improve the length of hospital stay and in-hospital mortality in patients with ADHF?
• Does early initiation of Dapagliflozin enhance the diuretic response, weight reduction and pro-BNP reduction in the acute stage of HF?
• Does early initiation of Dapagliflozin adversely affect the hemodynamic stability and kidney functions in the acute stage of HF? Participants will be randomized with the ratio of 1:1 within 24 hours of admission to receive Dapagliflozin 10 mg/day versus standard of care. Follow up will continue for 2 months after hospital discharge. Researchers will compare the in-hospital and 60-day clinical outcomes in the Dapagliflozin group versus the standard treatment group.

Conditions

Acute Heart Failure

Keywords

Dapagliflozin; Acute heart failure; Decompensated heart failure; Hospitalization; Sodium-glucose cotransporter-2 inhibitors

Outcome Measures

Primary Outcomes (4)

• All-cause mortality during hospitalization.

  Death from any cause during the period of hospital stay.

  From the date of admission until the date of discharge, average of 7 days

• Length of hospital stay

  The number of days from hospital admission to discharge.

  From the date of admission until the date of discharge, average of 7 days

• Diuretic response during the hospital phase.

  Defined as adjusted urine output and weight change per 40 mg of IV Furosemide or equivalent dose

  First 4 days of hospital admission

• Change in NT-proBNP at day 4 (or at discharge if earlier).

  The percentage change between baseline NT-proBNP on admission and NT-proBNP at day 4.

  First 4 days of hospital admission

Secondary Outcomes (4)

• Composite endpoint of cardiovascular death, re-admission for HF, or urgent clinic visit for decompensation at 2 months after hospital discharge.

  60 days after hospital discharge

• Change in serum NT-proBNP after 2 months.

  60 days after hospital discharge

• Worsening renal functions

  During hospital stay and up to 60 days after hospital discharge

• Composite endpoint of urogenital infections, hypoglycemic events, hypotension events or diabetic ketoacidosis.

  During hospital stay and up to 60 days after hospital discharge

Study Arms (2)

Dapagliflozin group

EXPERIMENTAL

This group will receive oral Dapagliflozin 10 mg once daily within 24 hours from hospital admission, in addition to the standard treatment for acute heart failure.

Drug: Dapagliflozin 10mg Tab

Standard group

NO INTERVENTION

This group will only receive the standard treatment for acute heart failure.

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin is a drug that works through inhibition of sodium glucose transporter-2 resulting in glucosuria.

Also known as: Sodium-glucose cotransporter-2 inhibitors

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients above 18 years presenting with acute heart failure defined as rapid development of dyspnea NYHA class III-IV associated with clinical signs of HF (e.g. congested neck veins, pulmonary rales, lower limb swelling, radiological evidence of pulmonary congestion) with LVEF ≤ 40%.

You may not qualify if:

• Cardiogenic shock on admission, defined as SBP \< 90 mmHg plus signs of peripheral hypoperfusion or the need of vasopressor or inotropic support.
• Estimated GFR \< 30 mL/min/1.73 m2.
• Pregnancy or lactation.
• Type I DM or history of DKA.
• Treatment with any SGLT2 inhibitor in the last month.
• Known intolerance to any SGLT2 inhibitor.
• Severe anemia (Hemoglobin \< 7 g/dl).

Sponsors & Collaborators

• Cairo University: lead
• Aswan Heart Centre: collaborator

Study Sites (2)

Aswan Heart Centre

Aswān, Egypt

Location

Kasr Al-Ainy Medical School

Cairo, 11562, Egypt

Location

Related Publications (3)

• Damman K, Beusekamp JC, Boorsma EM, Swart HP, Smilde TDJ, Elvan A, van Eck JWM, Heerspink HJL, Voors AA. Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF). Eur J Heart Fail. 2020 Apr;22(4):713-722. doi: 10.1002/ejhf.1713. Epub 2020 Jan 7.

  PMID: 31912605 BACKGROUND

• McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

  PMID: 31535829 BACKGROUND

• Ul Amin N, Sabir F, Amin T, Sarfraz Z, Sarfraz A, Robles-Velasco K, Cherrez-Ojeda I. SGLT2 Inhibitors in Acute Heart Failure: A Meta-Analysis of Randomized Controlled Trials. Healthcare (Basel). 2022 Nov 23;10(12):2356. doi: 10.3390/healthcare10122356.

  PMID: 36553880 BACKGROUND

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Magdy Abdelhamid, Professor

  Chairman of Cardiology Department, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Cardiology

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 25, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 26, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan.

Locations

EG (2)