The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement

Last updated: September 27, 2020
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04573049
2020-1357
  • Ages 18-100
  • All Genders

Study Summary

A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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

  2. Severe aortic stenosis

  3. Mean transaortic gradient ≥ 40 mmHg(at rest or stress)

  4. Aortic peak velocity ≥ 4m/s;

  5. Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2

  6. Cardiac dysfunction

  7. LVEF≤50% (estimated by Simpson)

  8. NT-proBNP≥1500ng/L;

  9. Symptoms of dyspnea and fatigue when at rest or after slight exertion (New YorkHeart Association ≥ Ⅲ -Ⅳ)

  10. Intermittant fluid retention and/or symptoms induced by low cardiac output atrest, but lack of hemodynamic instability

Exclusion

Exclusion Criteria:

  1. Decompensated acute cardiac failure due to hemodynamic instability

  2. A historty of torsade de points ventricular tachycardia

  3. Known allergic reaction or sensitivity to Levosimendan or excipients

  4. Received levosimendan within 1 week prior to the planned clinical trial

  5. Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study

  6. Systolic blood pressure < 90mmHg at baseline

  7. Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2.

  8. Unable to participate in study for being critically ill asssed by clinicians

  9. 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

Total Participants: 124
Study Start date:
September 01, 2020
Estimated Completion Date:
December 30, 2022

Study Description

The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.

Connect with a study center

  • Jianhui Wang

    Beijing, Beijing 100037
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.