JPRN-UMIN000048016Recruiting未知
Efficacy of empagliflozin on diastolic dysfunction during exercise stress echocardiography in patients with heart failure with preserved ejection fraction Prospective open-label randomized parallel-group study - SUMMIT study
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Mitsui Memorial Hospital
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 90years-old (—)
- Sex
- Male
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) eGFR< 20 mL/min/1.72m2 2) Already taking SGLT2 inhibitor 3) Type 1 DM 4) A clear cause of dyspnea on exertion other than heart failure 5) At risk of ketoacidosis or hyperosmotic hyperglycemia 6) Pregnant or lactating women 7) Severe regurgitation or moderate or severe stenotic valvular disease. Valve replacement surgery. 8) Regional wall motion disorder of the left ventricle that may cause inaccurate measurement of E/e'. 9) Cardiovascular surgery, implantable cardioverter-defibrillator, implantable cardioverter-defibrillator with biventricular pacing, implantable ventricular assist device, etc. within 30 days 10) Acute coronary syndrome, pulmonary thromboembolism, cerebral infarction, or transient ischemic attack within 90 days 11) Ventricular tachycardia with syncope noted within 90 days. 12) Heart transplantation, implantable artificial heart implantation, or palliative therapy. 13) Patients with severe valvular heart disease who are expected to undergo open heart surgery or catheterization therapy in the near future. 14) Amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, or muscular dystrophy. Takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complicated congenital heart disease, and heart failure due to pericardial contraction 15) Postpartum cardiomyopathy within 6 months 16) Active myocarditis 17) Uncontrolled thyroid disease 18) Symptomatic bradycardia or complete atrioventricular block. Permanent pacemaker implantation. 19) Severe hepatic dysfunction or cirrhosis with portal hypertension 20) Alcohol abuse 21) Active or suspected malignant tumors diagnosed within 2 years. 22) Comorbidities other than heart failure for which prognosis is not expected to be more than 1 year. 23) Participating in a clinical trial with another drug within 30 days 24) Other conditions that may interfere with patient safety or protocol compliance 25) Other patients deemed unsuitable by the investigator.
Investigators
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