Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)
- Conditions
- Chronic right heart failure
- Registration Number
- 2024-515044-23-01
- Lead Sponsor
- Universitaetsmedizin Goettingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
Known contraindication for the treatment with dapagfliflozin
Type 1 diabetes mellitus
Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
Known active alcohol and / or drug abuse
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
Known acute or chronic liver disease with clinical signs of severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)
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)
Pulmonary arterial hypertension (PAH, PH Group I)
Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
Active symptomatic infection (e. g. with body temperature ≥38°C) requiring anti-infective treatment (based on investigator's clinical judgement)
Acute (within 30 days) pulmonary embolism
Acute (within 30 days) right ventricular myocardial infarction
Current medication with any SGLT2 inhibitor
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
Systolic blood pressure (SBP) <90 mmHg at screening visit confirmed on 2 consecutive measurements
Any contraindication for cardiac magnetic resonance imaging (MRI)
Known intolerance or hypersensitivity to dapagliflozin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP) Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP)
- Secondary Outcome Measures
Name Time Method 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 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
Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment
Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment
Change in NYHA (New York Heart Association) class from baseline to end of treatment Change in NYHA (New York Heart Association) class from baseline to end of treatment
Trial Locations
- Locations (1)
Universitaetsmedizin Goettingen
🇩🇪Goettingen, Germany
Universitaetsmedizin Goettingen🇩🇪Goettingen, GermanyStephan von HaehlingSite contact05513920912stephan.von.haehling@med.uni-goettingen.de