Liver TransplantationNCT00778687
Heart Rate Variability Change After Liver Transplantation
An observational study of Liver Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage liver disease undergoing liver transplantation
Who may be able to join
- Age:18-70y/o receiving liver transplantation
Who cannot join
- History of cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liver Transplantation on the Heart Rate Variability in Patients With End-Stage Liver Disease
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.
- Conditions
- Liver Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778687
- Sponsor's protocol ID
- 200809046R
- Status last verified
- Dec 2013
- First submitted
- 22 Oct 2008
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19076059
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liver Transplantation on the Heart Rate Variability in Patients With End-Stage Liver Disease
- ClinicalTrials.gov ID
- NCT00778687
- Acronym / sponsor ID
- 200809046R
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage liver disease undergoing liver transplantation
Key inclusion criteria (1 listed)
- Age:18-70y/o receiving liver transplantation
Key exclusion criteria (1 listed)
- History of cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiscale entropy
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Background: PubMed 19076059Genovesi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiscale entropy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.