NCT00778687

Brief Summary

Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac output and low systemic vascular resistance. And the latent heart failure becomes obvious under physiologic and pharmacologic stress. The goal of our study is to assess the effects of liver transplantation on the heart rate variability in patients with end stage liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

October 22, 2008

Last Update Submit

December 22, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Multiscale entropy

    Multiscale entropy was measured at nine time points: 1. preoperative, 2. postoperative day 1, 3. postoperative day 2, 4. postoperative day 3, 5. postoperative day 4, 6. postoperative day 7, 7. postoperative day 14, 8. postoperative 3 months, 9. postoperative 6 months

    6 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end stage liver disease undergoing liver transplantation

You may qualify if:

  • Age:18-70y/o receiving liver transplantation

You may not qualify if:

  • History of cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Genovesi S, Prata Pizzala DM, Pozzi M, Ratti L, Milanese M, Pieruzzi F, Vincenti A, Stella A, Mancia G, Stramba-Badiale M. QT interval prolongation and decreased heart rate variability in cirrhotic patients: relevance of hepatic venous pressure gradient and serum calcium. Clin Sci (Lond). 2009 May 14;116(12):851-9. doi: 10.1042/CS20080325.

    PMID: 19076059BACKGROUND

Study Design

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

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations