Sodium glucose cotransporter-2 inhibitor dapagliflozin versus thiazide diuretic in patients with heart failure and diuretic resistance

Phase 1

• Conditions: Diuretic resistant heart failure; MedDRA version: 20.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10066159Term: Decompensated heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: PTClassification code 10053073Term: Diuretic therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004832-48-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-10
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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 <1kg) or absence of a negative fluid balance (decrease <1 litre) despite treatment with high dose IV loop diuretic (equivalent of =160 mg IV furosemide) over the preceding 24 hours

• Type 2 diabetes or pre-diabetes (prediabetes defined as HbA1c 39-47 mmol/mol)

• eGFR <60 ml/min/1.73m2 at the time of 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
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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified