NCT02285309

Brief Summary

This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:

  1. 1.The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
  2. 2.The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
  3. 3.The influence of drugs such as enoximone on these outcome measures.

Trial Health

50
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

8 months

First QC Date

November 4, 2014

Last Update Submit

November 4, 2014

Conditions

Diastolic Dysfunction

Keywords

Cardiac SurgeryDiastolic DysfunctionEnoximone

Outcome Measures

Primary Outcomes (1)

  • Change in diastolic dysfunction -categorised as improved, stable or worse

    Compare diastolic dysfunction before and after surgery in those that receive enoximone. Compare diastolic function before and after surgery in those that do not receive enoximone

    Up to 12 hours

Secondary Outcomes (7)

  • Systolic and diastolic data from the post operative transthoracic echocardiogram

    Up to 30 days

  • Duration of endotracheal intubation (in hours)

    0-30 days

  • Incidence of post operative atrial fibrillation

    0-30 days

  • Duration of ICU stay

    0-30 days

  • Duration of hospital stay

    0-30 days

  • +2 more secondary outcomes

Study Arms (1)

Cardiac surgery

Procedure: Cardiac Surgery and enoximone

Interventions

Cardiac Surgery and enoximonePROCEDURE

Does diastolic function change with cardiac surgery +/- enoximone

Cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any cardiac surgery

You may qualify if:

  • Systolic dysfunction (EF \<50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
  • Able to give informed consent

You may not qualify if:

  • Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cardiac Surgical ProceduresEnoximone

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Bonnie Kyle

CONTACT

02034567898bonniekyle@doctors.net.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 6, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Last Updated

November 6, 2014

Record last verified: 2014-11