Right heart failure 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 b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml c) Clinical signs of right cardiac congestion or need for diuretic therapy to prevent signs of congestion
Conditions
Interventions
Trade Name: FORXIGA
Product Name: Dapagliflozin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dapagliflozin
CAS Number: 960404-48-2
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The Patient is willing and able to participate and provide written informed consent; 2. Age = 18 years and 2,1 cm) with reduced collapsibility (125 pg/ml c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%) 2. Pulmonary arterial hypertension (PAH, PH Group I) 3. Acute (within 30 days) pulmonary embolism 4. Acute (within 30 days) right ventricular myocardial infarction 5. Current medication with any SGLT2 inhibitor 6. 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 7. Systolic blood pressure (SBP) <90 mmHg at randomization on 2 consecutive measurements 8. Any contraindication for cardiac magnetic resonance imaging (MRI) 9. Known intolerance or hypersensitivity to dapagliflozin 10. Known contraindication for the treatment with dapagfliflozin 11. Type 1 diabetes mellitus 12. Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent 13. Current participation in another interventional trial 14. Pregnancy or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic RHF compared to standard of care plus placebo.;Secondary Objective: To investigate the influence of dapagliflozin in patients with chronic right heart failure on secondary outcomes as changes in quality of life, right ventricular ejection fraction, exercise capacity, NYHA class, cardiac imaging parameters, renal function or laboratory parameters;Primary end point(s): Change in serum NT-proBNP level from baseline to end of treatment (Delta-NT-proBNP);Timepoint(s) of evaluation of this end point: End of treatment (week 12 and week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Four key secondary endpoints of equal importance have been defined: 1.) 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 2.) Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment 3.) Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment 4.) Change in NYHA class from baseline to end of treatment Other secondary endpoints 1.) Imaging secondary endpoints a. Cardiac MRI - Change in RV global strain and right atrial long-axis strain (LAS) on cardiac MRI - Number of patients with an improvement in RV EF (assessed on cardiac MRI) b. Echocardiography - Change in TAPSE (mm) - Change in PAPsys (mmHg) assessed in echocardiography - Number of patients with decrease in PAP sys =5 mmHg while TAPSE is at least stable 2.) Renal secondary endpoints - Change in renal arterial and venous flow parameters (as assessed by ultrasound sonography): ~ arterial flow: renal resistance index (RRI) ~ venous flow: venous flow pattern, venous impedance index (VII), renal venous stasis index (RVSI), venous velocity index (VVI) - Change in urine albumin and protein level - Change in serum levels of creatinine, eGFR - Number of patients with worsening renal function (WRF), defined as =0.3 mg/dl increase of serum creatinine and / or =10 % decrease of eGFR - Change in fractional excretion of sodium and urea - number of patients with predominance of diastolic flow of the liver vein [defined as VS/(VS + VD) < 55%] 3.) Laboratory secondary endpoints - Number of patients with =30% decrease of NT-proBNP level - Change in Alanine-Aminotransferase (ALAT) level 4.) Clinical secondary end | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Universitätsmedizin Göttingen
Outcome results
None listed