NCT04573049

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

September 15, 2020

Last Update Submit

September 27, 2020

Conditions

Aortic Valve StenosisHeart FailureInotropic AgentsSafety IssuesEffect of DrugCardiac EventTranscatheter Aortic Valve Replacement

Keywords

Aortic valve stenosisHeart failureLevosimendanTranscatheter Aortic Valve ReplacementEffectivenessSafetyNT-proBNP

Outcome Measures

Primary Outcomes (1)

  • The change of NT-proBNP level

    day 1, day 3, day 5, month 1 and month 3

Secondary Outcomes (6)

  • The change of CK-MB

    day 1, day 3, day 5, month 1 and month 3

  • The change of c-TnI

    day 1, day 3, day 5, month 1 and month 3

  • The change of left ventricular ejection fraction

    day 1, day 3, day 5, month 1 and month 3

  • The change of left ventricular end-diastolic diameter

    day 1, day 3, day 5, month 1 and month 3

  • The number of patients in need of secondary intra-operative vasoactive-inotropic substances

    Peri-operation

  • +1 more secondary outcomes

Other Outcomes (6)

  • The incidence of adverse events

    Peri-operation

  • The incidence of atrial fibrillation

    Peri-operation

  • The change of electrolyte

    Peri-operation

  • +3 more other outcomes

Study Arms (2)

Levosimendan

EXPERIMENTAL

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

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

LevosimendanDRUG

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

Levosimendan
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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 York Heart Association ≥ Ⅲ -Ⅳ)
  • Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianhui Wang

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisHeart FailureCardiovascular Diseases

Interventions

Simendan

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jianhui Wang, MD

CONTACT

010-88398082stewenwang@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator and Clinical professor

Study Record Dates

First Submitted

September 15, 2020

First Posted

October 5, 2020

Study Start

September 1, 2020

Primary Completion

April 1, 2022

Study Completion

December 30, 2022

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

CN(1)