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

NCT04573049 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-10-05

No results posted yet for this 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

Conditions

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

Interventions

DRUG

Levosimendan

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

OTHER

Placebo

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

Sponsors & Collaborators

  • China International Medical Foundation

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-04-01
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573049 on ClinicalTrials.gov