End Stage Renal DiseaseNCT00296543
T Wave Alternans in Hemodialysis
An observational study of End Stage Renal Disease and Coronary Heart Disease, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Coronary Heart Disease, Congestive Heart Failure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with heart disease and/or poor cardiac function
Who may be able to join
- 18 years of age or older
- Normal sinus rhythm
Who cannot join
- Inability to give written informed consent
- Active cardiac ischemia
- Pacemaker
- Inability to perform a brief walking treadmill test
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46032
About this study
Official title: Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.
Read the detailed description
One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.
- Keywords
- hemodialysis, sudden cardiac death
- Medical subject headings
- Kidney Failure, Chronic, Coronary Disease, Heart Failure, Death, Sudden, Cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startOct 2005
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Investigators
- Allon Friedman, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296543
- Sponsor's protocol ID
- 0508-02
- Status last verified
- Jun 2011
- First submitted
- 23 Feb 2006
- Last updated
- 20 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00296543
- Acronym / sponsor ID
- 0508-02
- Keywords
- hemodialysis, sudden cardiac death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- Oct 2005
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Feb 2006 (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.
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.
Detailed description
One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with heart disease and/or poor cardiac function
Key inclusion criteria (2 listed)
- 18 years of age or older
- Normal sinus rhythm
Key exclusion criteria (4 listed)
- Inability to give written informed consent
- Active cardiac ischemia
- Pacemaker
- Inability to perform a brief walking treadmill test
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
Not reported in the source record.
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 20 Jun 2011.
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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.
Allon Friedman, MD principal investigator
Indiana University
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 End Stage Renal Disease and Coronary Heart Disease, run by Indiana University at 1 site in United States.
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 2 inclusion and 4 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 20 Jun 2011. 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 United States. 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.
Where can I read the original study information?
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 20 Jun 2011.