Last updated: March 5, 2023
Sponsor: Zhijun Sun
Overall Status: Active - Enrolling
Phase
4
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
N/AClinical Study ID
NCT05600387
2022PS1015K
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years old, BMI18.5-27.9kg/m²
- Meet the definition of chronic heart failure and an ejection fraction of 40% or more (according to 2021 ESC Guidelines for the diagnosis and treatment of acute and chronicheart failure)
- Elevated NT-proBNP levels of more than 300 pg/mL
- Signed and dated written informed consent form
Exclusion
Exclusion Criteria:
- Myocardial infarction,coronary artery bypass graft surgery, or other majorcardiovascular surgery within 30 days after enrollment
- Percutaneous coronary intervention ,coronary artery bypass graft surgery,cardiacresynchronization therapy, implantable cardioverter defibrillatoror or other cardiacsurgeries within 90 days prior to enrollment
- Atrial fibrillation or flutter
- SGLT-2i using within 90 days prior to enrollment
- Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulationdiseases (e.g. haemochromatosis, Fabry disease),cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction
- Acute decompensated heart failure.
- Moderate to severe valvular stenosis or regurgitation
- Symptomatic hypotension with systolic pressure ≤ 90mmHg or uncontrolled hypertensionusing drugs with systolic blood pressure of ≥180 mmHg at randomization
- Sever infectious diseases(e.g. Severe myocarditis, severe pneumonia, and severeurinary tract infection)
- Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy orhospitalization for exacerbation within 12 months
- Other significant co-morbid conditions(impaired renal function( an estimatedglomerular filtration rate of <20 mL/min/1.73 m2), hepatic failure, malignant tumors,severe hematologic diseases, etc.)
- Major surgery performed within 90 days prior to enrollment or major scheduled electivesurgery within 90 days after enrollment(major according to the investigator'sassessment,such as gastrointestinal surgery that might interfere with trial medicationabsorption or malignant tumors surgery)
- Type 1 diabetes or history of ketoacidosis
- Pregnancy
- Completion within 90 days of a trial of another drug study. Receipt of anyinvestigative treatment other than the study medications for this trial
Study Design
Total Participants: 100
Study Start date:
November 05, 2022
Estimated Completion Date:
October 31, 2025
Study Description
Connect with a study center
Shengjing Hospital
Shenyang, Liaoning 110004
ChinaSite Not Available
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