Diuretic resistant heart failure MedDRA version: 20.0 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10066159 Term: Decompensated heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: PT Classification code 10053073 Term: Diuretic therapy System Organ
Conditions
Interventions
Trade Name: Forxiga
Product Name: Forxiga
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dapagliflozin propanediol monohydrate
CAS Number: 461432-26-8
Current Sponsor code: Not applicabl
Sponsors
NHS Greater Glasgow and Clyde
University of Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female =18 years of age • Informed consent • Primary reason for admission to hospital is worsening HF meeting the European Society of Cardiology (ESC) definition • Diuretic Resistance as defined as lack of weight loss (decrease 3 days Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Inability to give informed consent e.g. due to significant cognitive impairment • Intravascular volume depletion based on investigator’s clinical assessment • eGFR <20 mL/min/1.73 m2 • Alternative explanation for worsening renal function such as obstructive nephropathy, contrast induced nephropathy, or acute tubular necrosis • Enrolment in another randomized clinical trial involving medical or device-based interventions (co-enrolment in observational studies is permitted) • Women of child-bearing potential • History of allergy to SGLT2i or thiazide or thiazide-like diuretics or any of the excipients • Hypertrophic obstructive cardiomyopathy (HOCM) or severe stenotic valvular disease • SGLT2i, thiazide or thiazide-like diuretics administration in the previous 48 hours prior to randomisation • Active genital tract infections • Anyone who, in the investigators’ opinion, is not suitable to participate in the trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the diuretic effect of dapagliflozin compared to metolazone, as assessed by mean change in weight, in hospitalised heart failure patients with diuretic resistance, type 2 diabetes or prediabetes and renal impairment.;Secondary Objective: To assess the effect of dapagliflozin compared to metolazone on congestion (as assessed by lung ultrasound), loop diuretic efficiency (defined as weight loss in kilograms divided by furosemide equivalents in milligrams), laboratory tests (heart and kidney), heart failure symptoms, length of hospital stay, hospital readmissions and mortality.;Primary end point(s): Diuretic effect, as assessed by mean change in weight, from randomisation to 48, 72 and 96 hours.;Timepoint(s) of evaluation of this end point: 48, 72 and 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in congestion, assessed using lung ultrasound, from randomisation to 48, 72 and 96 hours • Loop diuretic efficiency assessed at 48, 72 and 96 hours. Loop diuretic efficiency will be defined as weight loss in kilograms divided by furosemide equivalents in milligrams. ;Timepoint(s) of evaluation of this end point: 48, 72 and 96 hours | — |
Countries
United Kingdom
Contacts
Public ContactMaureen Travers
NHS Greater Glasgow and Clyde
Outcome results
None listed