I07.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Severe functional tricuspid regurgitation Heart failure symptoms (NYHA = II, peripheral edema, ascites, pleural effusion, pulmonary edema, KCCQ = 50 points) Stable GDMT for at least six weeks Life expectancy > 12 months Signed informed consent
Exclusion criteria
Exclusion criteria: Severe mental disorders, drug/alcohol dependency Unstable patients (e.g., cardiogenic shock, severe cardiac decompensation) Patients with HFrEF Severe renal impairment (eGFR GOLD II Precapillary pulmonary hypertension (Group 1) Presence of an allergic reaction to SGLT2 inhibitors Type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint of absolute changes in KCCQ and corrected PISA-EROA after three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints also include changes in the severity of TI, right ventricular function, physical capacity, and changes in NTproBNP levels. | — |
Countries
Germany
Contacts
Universitätsklinikum Bonn