Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed (by the subjects or their legally acceptable representatives) informed consentdocument indicating that they understand the purpose of and procedures required forthe study and are willing to participate in the study
Severe aortic stenosis
Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
Aortic peak velocity ≥ 4m/s;
Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2
Cardiac dysfunction
LVEF≤50% (estimated by Simpson)
NT-proBNP≥1500ng/L;
Symptoms of dyspnea and fatigue when at rest or after slight exertion (New YorkHeart Association ≥ Ⅲ -Ⅳ)
Intermittant fluid retention and/or symptoms induced by low cardiac output atrest, but lack of hemodynamic instability
Exclusion
Exclusion Criteria:
Decompensated acute cardiac failure due to hemodynamic instability
A historty of torsade de points ventricular tachycardia
Known allergic reaction or sensitivity to Levosimendan or excipients
Received levosimendan within 1 week prior to the planned clinical trial
Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
Systolic blood pressure < 90mmHg at baseline
Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2.
Unable to participate in study for being critically ill asssed by clinicians
Other concomitant severe morbidities leading to poor prognosis and decreasedmortality, such as malignant tumor and disease involving other vital organs; lifeexpectancy less than 1 year.
Study Design
Study Description
Connect with a study center
Jianhui Wang
Beijing, Beijing 100037
ChinaActive - Recruiting
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