Phase
Condition
Congestive Heart Failure
Treatment
Carvedilol+Empagliflozin
Carvedilol
Empagliflozin
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must agree to the study protocol and provide written informed consent
Outpatients ≥ 20 years of age, male or female
Patients with severe functional tricuspid regurgitation
TR whose vena contracta ≥0.7cm or central jet area > 10 square cm and whichlasted > 6 months under medical treatment
LV ejection fraction ≥ 50%
Dyspnea of NYHA functional class II or III
Exclusion
Exclusion Criteria:
History of hypersensitivity or allergy to the study drugs, drugs of similar chemicalclasses, as well as known or suspected contraindications to the study drug
Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
Significant left-sided valve disease
Left ventricular ejection fraction <40%
Marked bradycardia (<50 beats/min) or 2nd or 3rd degree AVB, sinus node dysfunction
Severe pulmonary hypertension: TR Vmax >4m/s at screening (including Cor pulmonale)
Medical history of hospitalization within 6 weeks
Current acute decompensated heart failure or dyspnea of NYHA functional class IV
Symptomatic hypotension and/or a SBP < 90 mmHg at screening Estimated GFR < 30mL/min/1.73 square m
History of ketoacidosis, Type 1 diabetes
Evidence of hepatic disease as determined by any one of the following: AST or ALTvalues exceeding 2 x upper limit of normal (ULN) at screening visit (Visit 0),history of hepatic encephalopathy, history of esophageal varices, or history ofportocaval shunt.
Acute coronary syndrome, stroke, severe peripheral artery disease or major CVsurgery or PCI within 3 months
History of severe pulmonary disease (asthma, COPD with bronchial hypersensitivity)
Secondary hypertension such as pheochromocyotoma
Acute pulmonary thromboembolism
Variant angina, vocal cord edema, severe allergic rhinitis
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using a barrier method plus a hormonal method
Pregnant or nursing (lactating) women
Contraindication for MRI
Presence of pacemaker or ICD, implanted metallic objects, claustrophobia
Severe beat-to-beat variation
Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
Any clinically significant abnormality identified at the screening visit, physicalexamination, laboratory tests, or electrocardiogram which, in the judgment of theinvestigator, would preclude safe completion of the study
Study Design
Study Description
Connect with a study center
Asan Medical Center
Seoul, 138-736
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available

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