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

NCT ID: NCT04573049

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-30

Brief 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

Detailed 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.

Conditions

Aortic Valve Stenosis; Heart Failure; Inotropic Agents; Safety Issues; Effect of Drug; Cardiac Event; Transcatheter Aortic Valve Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Levosimendan

Levosimendan 0.1µg/kg/min will last for 24h after the valve is released.

Group Type: EXPERIMENTAL

Levosimendan

Intervention Type: DRUG

On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours.

Placebo

5% glucose 0.1µg/kg/min administration will continue for 24h after the valve is released.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours.

Interventions

Levosimendan

On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours.

Intervention Type: DRUG

Placebo

On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

2. Severe aortic stenosis

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

2. Aortic peak velocity ≥ 4m/s;

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

3. Cardiac dysfunction

1. LVEF≤50% (estimated by Simpson)

2. NT-proBNP≥1500ng/L；

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

4. Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability

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 decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Medical Foundation

OTHER

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jianhui Wang

Principle Investigator and Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jianhui Wang

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianhui Wang, MD

Role: CONTACT

stewenwang@sina.com

010-88398082

Facility Contacts

Jianhui Wang, MD

Role: primary

stewenwang@sina.com

010-88398082

Other Identifiers

2020-1357

Identifier Type: -

Identifier Source: org_study_id