Status:
UNKNOWN
DAPAgliflozin Versus Thiazide Diuretic in Patients With Heart Failure and Diuretic RESISTance
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the effect of dapagliflozin compared with metolazone, added to furosemide, on diuresis and decongestion in hospitalised heart failure patients with diuretic resistance, and renal impairment....
Detailed Description
The investigators aim to assess whether SGLT2i (in addition to IV loop diuretic) results in greater diuresis and decongestion compared to the standard practice of treatment with the thiazide-like diur...
Eligibility Criteria
Inclusion
- \- 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.14
- Diuretic Resistance as defined as: Lack of weight loss or absence of a negative fluid balance (as defined above) over the preceding 24 hours despite treatment with high dose IV loop diuretic (equivalent of ≥160mg IV furosemide in 24 hours)
- Plasma BNP ≥ 100 pg/mL or plasma NT-proBNP ≥ 400 pg/mL in current hospital admission
- eGFR \<60 ml/min/1.73m2 required within 24 hours before randomisation
- Ongoing clinical evidence of congestion: pitting peripheral oedema and/or ascites and/or elevated jugular venous pressure, and/or radiographic or ultrasonic evidence of pulmonary congestion
- Expected hospital length of stay \>3 days
Exclusion
- 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
- Enrollment in another randomised 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 significant valvular disease in whom surgical or percutaneous repair or replacement may be considered.
- 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
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04860011
Start Date
April 27 2021
End Date
April 3 2023
Last Update
April 10 2023
Active Locations (2)
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1
Glasgow Royal Infirmary
Glasgow, Strathclyde, United Kingdom, G4 0SF
2
Queen Elizabeth University Hospital
Glasgow, Strathclyde, United Kingdom, G51 4TF