Right Ventricular HypertrophyNCT01430897
Right Ventricular Hypertrophy After Atrial Switch and Cardiovascular Magnetic Resonance (CMR) Findings
An observational study of Right Ventricular Hypertrophy and d-TGA, run by University of Leipzig at 1 site in Germany.
Trial summary
Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Right Ventricular Hypertrophy, d-TGA
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Sep 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Thirty-seven consecutive patients who came to regular outpatient visits at our tertiary care institution were referred to CMR. Patient parameters were compared to a control group of 25 healthy age matched volunteers.
Who may be able to join
- Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects.
Who cannot join
- Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Hypertrophy After Atrial Switch Operation and Its Role in a Systemic RV: Normal Adaptation Process or Risk Factor? A Cardiovascular Magnetic Resonance Study
Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV).
In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.
- Conditions
- Right Ventricular Hypertrophy, d-TGA
- Keywords
- d-TGA, dextro Transposition of the great arteries, systemic right ventricle, right ventricular failure, Atrial switch procedure
- Medical subject headings
- Hypertrophy, Right Ventricular, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startApr 2007
- Primary completionApr 2011
- Study completionSep 2011
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 Right Ventricular HypertrophyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Grothoff, M.D., University of Leipzig
- Investigators
- Matthias Gutberlet, MD, Study chair, University pf Leipzig - Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430897
- Sponsor's protocol ID
- 261-11-22082011
- Status last verified
- Sep 2011
- First submitted
- 5 Sep 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hornung TS, Kilner PJ, Davlouros PA, Grothues F, Li W, Gatzoulis MA. Excessive right ventricular hypertrophic response in adults with the mustard procedure for transposition of the great arteries. Am J Cardiol. 2002 Oct 1;90(7):800-3. doi: 10.1016/s0002-9149(02)02619-x. No abstract available.
PubMed 12356407
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Hypertrophy After Atrial Switch Operation and Its Role in a Systemic RV: Normal Adaptation Process or Risk Factor? A Cardiovascular Magnetic Resonance Study
- ClinicalTrials.gov ID
- NCT01430897
- Acronym / sponsor ID
- 261-11-22082011
- Conditions
- Right Ventricular Hypertrophy, d-TGA
- Keywords
- d-TGA, dextro Transposition of the great arteries, systemic right ventricle, right ventricular failure, Atrial switch procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Sep 2011 (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.
Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV).
In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty-seven consecutive patients who came to regular outpatient visits at our tertiary care institution were referred to CMR. Patient parameters were compared to a control group of 25 healthy age matched volunteers.
Key inclusion criteria (1 listed)
- Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects.
Key exclusion criteria (1 listed)
- Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.
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 8 Sep 2011.
- Results publication: PubMed 12356407Hornung TS, Kilner PJ, Davlouros PA, Grothues F, Li W, Gatzoulis MA. Excessive right ventricular hypertrophic response in adults with the mustard procedure for transposition of the great arteries. Am J Cardiol. 2002 Oct 1;90(7):800-3. doi: 10.1016/s0002-9149(02)02619-x. No abstract available.
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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.
Matthias Gutberlet, MD study chair
University pf Leipzig - Heart Center
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 Right Ventricular Hypertrophy and d-TGA, run by University of Leipzig at 1 site in Germany.
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 8 Sep 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 Germany. 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?
On the ClinicalTrials.gov record for NCT01430897, 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 8 Sep 2011.