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Recruiting NCT05686616

SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Conditions: Tricuspid Regurgitation

Sex: All
Ages: 20 Years – 90 Years
Phase: NA
Enrollment: 72
Sponsor: Samsung Medical Center

Location: Korea, Republic of

Summary

The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.

Eligibility Criteria

Inclusion Criteria:Participant over 20 years of age who understands the research protocol and has written informed consentParticipant with severe tricuspid valve regurgitationVena contracta width > 0.7cm or effective regurgitant orifice (ERO)≥40mm2 for more than 1 month despite medical treatmentParticipant with left ventricular ejection fraction ≥ 40%Participant with NYHA class II or moreExclusion Criteria:Patient with severe mitral valve or aortic valve diseaseLeft ventricular ejection fraction less than 40%*Patient with severe pulmonary hypertension (TR Vmax > 4m/s)Patient with acute heart failure or dyspnea of NYHA functional class IV or higherSymptomatic hypotension or systolic blood pressure < 90 mmHg at screeningPatient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism)Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysisPatient with Type 1 diabetesIf a woman of childbearing potential has not used double contraceptionPatients with claustrophobia or with metallic implants unsuitable for magnetic resonance imagingBlood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)Life expectancy is less than one yearPatient who already take SGLT-2 inhibitorA history of hypersensitivity or allergy to SGLT2 inhibitor

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05686616). StuddyBuddy aggregates publicly available trial information.