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

Prior treatment

• 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

Other illness

• 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

Lab values

• 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

Other

• 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

• 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