Adding dapagliflozin (SGLT2i) to intravenous loop diuretic therapy for management of acute and residual congestion in hospitalized patients with acute heart failure

Adding Sodium Glucose Cotransporter-2 inhibitor dapagliflozin to intravenous loop diuretic therapy for management of acute and residual congestion in hospitalized patients with acute heart failure: a single-center, open-label, randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17064177

Enrollment

100

Registered

2025-03-03

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment in hospitalized patients with acute heart failure. Circulatory System

Interventions

Patients were randomly assigned to two groups: (A) to receive dapagliflozin 10 mg once daily in addition to a structured intravenous furosemide therapy within 24 hours from admission

(B) to receive structured intravenous furosemide therapy alone. At baseline, each patient was assessed for the following parameters: natriuretic peptide and CD146 serum concentration, standing weight

it was introduced by the investigators in the EVEREST trial. Lung ultrasound was performed on a Siemens Acuson SC2000 ultrasound machine using a phased array transducer and an eight-zone protocol (fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (male or female) aged over 18 years 2. Admitted for an episode of acute heart failure, regardless of ejection fraction or diabetes status. NT-proBNP = 400 pg/mL 3. eGFR > 25 mL/min/1.73 m² 4. Clinical and paraclinical signs of congestion

Exclusion criteria

Exclusion criteria: 1. Infections 2. Active cancer 3. Severe aortic stenosis 4. Exacerbated COPD 5. Pulmonary embolism 6. Acute coronary syndrome

Design outcomes

Primary

Measure	Time frame
1. Congestion relief: changes in congestion markers from baseline (at hospital admission) to discharge: weight change, EVEREST score, lung ultrasound B-lines, inferior vena cava echo measurement, NT-proBNP, and cluster of differentiation 146 (CD146). 2. Safety: changes in renal function (such as worsening renal function, and serum electrolyte abnormalities, including hypo/hyperkalemia or hyponatremia), and any adverse events documented daily from admission until discharge. Worsening renal function is defined as any increase in creatinine level > 0.3 mg/dL from baseline, hypokalemia ( 5.5 mmol/L), or hyponatremia (< 130 mmol/L).	—

Measure

Time frame

1. Congestion relief: changes in congestion markers from baseline (at hospital admission) to discharge: weight change, EVEREST score, lung ultrasound B-lines, inferior vena cava echo measurement, NT-proBNP, and cluster of differentiation 146 (CD146). 2. Safety: changes in renal function (such as worsening renal function, and serum electrolyte abnormalities, including hypo/hyperkalemia or hyponatremia), and any adverse events documented daily from admission until discharge. Worsening renal function is defined as any increase in creatinine level > 0.3 mg/dL from baseline, hypokalemia ( 5.5 mmol/L), or hyponatremia (< 130 mmol/L).

—

Secondary

Measure	Time frame
1. Diuresis and natriuresis (mean diuresis over three days, 24-hour urinary sodium output, and total furosemide dose per hospitalization); 2. Hospitalization duration, 30-day heart failure readmissions, and mortality measured using patient records; 3. One-month echocardiographic changes in heart failure function (ejection fraction, left-ventricular end-diastolic volume, systolic pulmonary artery pressure; global longitudinal strain and right ventricle strain).	—

Measure

Time frame

1. Diuresis and natriuresis (mean diuresis over three days, 24-hour urinary sodium output, and total furosemide dose per hospitalization); 2. Hospitalization duration, 30-day heart failure readmissions, and mortality measured using patient records; 3. One-month echocardiographic changes in heart failure function (ejection fraction, left-ventricular end-diastolic volume, systolic pulmonary artery pressure; global longitudinal strain and right ventricle strain).

—

Countries

Romania

Contacts

Public ContactAdina;Daniela Pop-Moldovan;Mocan

;

pop-moldovan.adina@uvvg.ro;hoza-mocan.daniela@student.uvvg.ro+40 257220000;+40 257220000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026