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The Effect of SGLT2 Inhibitors on Symptomatic Functional Tricuspid Regurgitation

The Effect of SGLT2 Inhibitors on Symptomatic Functional Tricuspid Regurgitation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035120
Enrollment
150
Registered
2024-10-16
Start date
2024-11-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I07.1

Interventions

Group 1: Group with SGLT2 inhibitor: Participants are divided into two groups: the exposure group receives therapy with an SGLT2 inhibitor combined with a diuretic due to existing indications (heart f

Sponsors

Universitätsklinikum Bonn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Combined endpoint of absolute changes in KCCQ and corrected PISA-EROA after three months.

Secondary

MeasureTime 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

Public ContactCan Öztürk

Universitätsklinikum Bonn

can.oeztuerk@ukbonn.de+4022828715335

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026