dapagliflozin for Chronic right heart failure

Inclusion criteria

• {"criterion_text":"- The Patient is willing and able to participate and provide written informed consent"}
• {"criterion_text":"- Age ≥ 18 years and < 90 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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 criteria

• {"criterion_text":"- Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)"}
• {"criterion_text":"- Known contraindication for the treatment with dapaglifliflozin"}
• {"criterion_text":"- Type 1 diabetes mellitus"}
• {"criterion_text":"- Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent"}
• {"criterion_text":"- Known active alcohol and / or drug abuse"}
• {"criterion_text":"- Current participation in another interventional trial"}
• {"criterion_text":"- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site)"}
• {"criterion_text":"- Pregnancy or lactating women"}
• {"criterion_text":"- Body mass index >50 kg/m2"}
• {"criterion_text":"- Known acute or chronic liver disease with clinical signs of severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pulmonary arterial hypertension (PAH, PH Group I)"}
• {"criterion_text":"- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization"}
• {"criterion_text":"- Active symptomatic infection (e. g. with body temperature ≥38°C) requiring anti-infective treatment (based on investigator's clinical judgement)"}
• {"criterion_text":"- Acute (within 30 days) pulmonary embolism"}
• {"criterion_text":"- Acute (within 30 days) right ventricular myocardial infarction"}
• {"criterion_text":"- Current medication with any SGLT2 inhibitor"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Systolic blood pressure (SBP) <90 mmHg at screening visit confirmed on 2 consecutive measurements"}
• {"criterion_text":"- Any contraindication for cardiac magnetic resonance imaging (MRI)"}
• {"criterion_text":"- Known intolerance or hypersensitivity to dapagliflozin"}

Primary endpoints

• {"endpoint_text":"- Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP)","definition_or_measurement_approach":"Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP) as stated; no further measurement details provided in source."}

Secondary endpoints

• {"endpoint_text":"- Change in quality of life assessed by overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) (a specific HF patient reported outcome questionnaire) from baseline to end of treatment","definition_or_measurement_approach":"Change in KCCQ overall summary score from baseline to end of treatment as stated."}
• {"endpoint_text":"- Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment","definition_or_measurement_approach":"Change in RV ejection fraction assessed by cardiac MRI from baseline to end of treatment as stated."}
• {"endpoint_text":"- Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment","definition_or_measurement_approach":"Change in 6-minute walk distance in meters from baseline to end of treatment as stated."}
• {"endpoint_text":"- Change in NYHA (New York Heart Association) class from baseline to end of treatment","definition_or_measurement_approach":"Change in NYHA class from baseline to end of treatment as stated."}

Germany

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

30-08-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universitaetsmedizin Goettingen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany