Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)

Trial details

Who runs it

Universitaetsmedizin Goettingen

Trial code

EU 2024-515044-23-01

Record updated

2024. augusztus 30.

Original description

To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic right heart failure compared to standard of care plus placebo.Read full original descriptionShow less

To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic right heart failure compared to standard of care plus placebo.

Inclusion: The Patient is willing and able to participate and provide written informed consent; Age ≥ 18 years and < 90 years; Presence of RHF defined as (criteria a-c must all be fulfilled): a) Reduced right ventricular systolic function or RV strain defined as at least one of the following  tricuspid annular plane systolic excursion (TAPSE) <16 mm  RV fractional area change (FAC) <35%  Systolic pulmonary artery pressure (PAP sys) ≥35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion; For women of childbearing potential* (until 1 year after menopause): a) Negative pregnancy test AND b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration.

Exclusion: Known contraindication for the treatment with dapagfliflozin; Known active alcohol and / or drug abuse; Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization; Current medication with any SGLT2 inhibitor; Type 1 diabetes mellitus; Known acute or chronic liver disease with clinical signs of severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy); Pulmonary arterial hypertension (PAH, PH Group I); Active symptomatic infection (e. g. with body temperature ≥38°C) requiring anti-infective treatment (based on investigator's clinical judgement); Acute (within 30 days) right ventricular myocardial infarction; Any contraindication for cardiac magnetic resonance imaging (MRI); Known intolerance or hypersensitivity to dapagliflozin; Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%); Hepatic impairment defined as aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment); Chronic kidney disease (CKD) or acute kidney injury with eGFR < 25 ml/min/1,73 m², or end-stage renal failure with the need for chronic dialysis treatment; Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent; Current participation in another interventional trial; Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site); Pregnancy or lactating women; Body mass index >50 kg/m2; Acute (within 30 days) pulmonary embolism; Systolic blood pressure (SBP) <90 mmHg at screening visit confirmed on 2 consecutive measurements.

EU CTIS 2024-515044-23-01