Status:
COMPLETED
Pharmacological Reduction of Right Ventricular Enlargement
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical Corporation
Conditions:
Tricuspid Regurgitation
Right Ventricular Dilatation
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation. Regardless of left ventricular (LV) functio...
Detailed Description
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation. The prevalence of functional TR was reporte...
Eligibility Criteria
Inclusion
- 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 which lasted \> 6 months under medical treatment
- LV ejection fraction ≥ 50%
- Dyspnea of NYHA functional class II or III
Exclusion
- History of hypersensitivity or allergy to the study drugs, drugs of similar chemical classes, 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 \< 30 mL/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 ALT values exceeding 2 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt.
- Acute coronary syndrome, stroke, severe peripheral artery disease or major CV surgery 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 of becoming 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, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04345796
Start Date
February 15 2021
End Date
June 3 2024
Last Update
April 6 2025
Active Locations (3)
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1
Asan Medical Center
Seoul, South Korea, 138-736
2
Samsung Medical Center
Seoul, South Korea
3
Seoul National University Hospital
Seoul, South Korea