Last updated: February 18, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Mitral Valve Regurgitation
Congestive Heart Failure
Treatment
rehydration
CMR
UCG
Clinical Study ID
NCT06266858
SYSKY-2022-407-02
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age ≥ 18 years old
- all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) :
- EROA ≥0.3cm^2; 2) RVol ≥45ml
- The patient has signed an informed consent form.
Exclusion
Exclusion Criteria:
- unstable angina, acute myocardial infarction and surgical history of coronary arterybypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 monthsbefore recruit
- acute heart failure or acute worsening of chronic heart failure requiring vasoactivedrug therapy
- severe infections, septicaemia
- severe hepatic insufficiency ( Child-Pugh class C)
- severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimatedglomerular filtration rate (eGFR) <15ml/min or dialysis)
- hypotensive state, shock ( systolic blood pressure <90mmHg or mean arterial pressure <70mmHg with tissue hypoperfusion and urine output <30ml/h)
- uncontrolled diseases of the haematological system: acute gastrointestinal bleeding,intracranial haemorrhage or haemorrhage from other organs, acute pulmonary embolism ordeep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia,anaphylactic purpura and acute leukaemia, severe abnormalities in haematologicalparameters such as platelet count <20*10^9/l and international normalized ratio (INR) >3
- contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophagealconstriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervicalvertebral instability
- contraindication for CMR such as metal foreign matter in the body, claustrophobia
- contraindication for intravenous anaesthesia such as allergy to anaesthetics
- pregnancy or breastfeeding
- The patient does not sign an informed consent form.
- Due to other reasons the patient is not suitable for enrollment assessed by theresearcher.
Study Design
Total Participants: 150
Treatment Group(s): 4
Primary Treatment: rehydration
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
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