SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-89
SponsorUniversity of Palermo

About this trial

The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 (SGLT-2) inhibitor among patients admitted for acute exacerbation of heart failure, in determining a significant increase in diuresis and natriuresis. It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

acute heart failure;

diabetes type 2.

Disqualifiers

low estimated glomerular filtration rate;

hypernatremia;

diabetes type 1;

non-cardiac causes of dyspnea;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin tablet

    Drug

    Dapagliflozin 10 mg 1 tablet once daily

  • Hypertonic Saline Solution, 1 Ml

    Drug

    Intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily

  • Furosemide Injection

    Drug

    Furosemide 20 mg

Treatment groups

544 Participants
are divided into 4 treatment groups
Group A: Dapa-TonicExperimental treatment 2 interventions
Group B: Tonic-PlaceboPlacebo comparator 1 intervention
Group C: Furosemide-PlaceboPlacebo comparator 1 intervention
Group D: Dapa-FuroActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Diuresis from the baseline and up to 1 week

Daily urinary volume (mL) are detected by chemiluminescence immunoassay.

Time frame
an average of 1 week
2

Natriuresis from the baseline and up to 1 week

Daily natriuresis (mEq/L) are detected by chemiluminescence immunoassay.

Time frame
an average of 1 week
3

Length of hospital stay

Duration of hospital stay in days.

Time frame
immediately after the intervention

Secondary outcomes

1

Kidney function during treatment

Daily evaluation of creatinine (mg/dL).

Time frame
an average of 1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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