D-Transposition of Great ArteriesNCT00412685
Myocardial Contrast Echocardiography in Congenital Heart Disease
An observational study of D-Transposition of Great Arteries and Tetralogy of Fallot, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- D-Transposition of Great Arteries, Tetralogy of Fallot
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Dec 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is divided in three groups, which are all age- and gender-matched. The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. The TOF group consists of 15 patients with surgically corrected TOF. The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.
Who may be able to join
- D-TGA or Fallot-Tetralogy or Healthy person
- written informed consent
- Age >= 18 years
Who cannot join
- Anaemia
- Pregnancy and breast feeding
- Diabetes mellitus
- Contraindications to stress testing (ergometry or adenosine)
- Known adverse reaction or hypersensitivity against V08DA (SonoVue) or its components or against adenosine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease
Patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. The aim of this study is to investigate the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in order to determine whether disturbed blood flow plays a role in the development of right ventricular systolic dysfunction.
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TGA group | The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. | |
| TOF group | The TOF group consists of 15 patients with surgically corrected TOF. | |
| Control group | The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D-Transposition of Great ArteriesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Christian Seiler, Prof., Principal investigator, University Hospital Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412685
- Sponsor's protocol ID
- 70/06
- Status last verified
- Jun 2015
- First submitted
- 15 Dec 2006
- Last updated
- 16 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00412685
- Acronym / sponsor ID
- 70/06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Dec 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.
Patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. The aim of this study is to investigate the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in order to determine whether disturbed blood flow plays a role in the development of right ventricular systolic dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TGA group | – | –The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. |
| TOF group | – | –The TOF group consists of 15 patients with surgically corrected TOF. |
| Control group | – | –The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is divided in three groups, which are all age- and gender-matched. The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. The TOF group consists of 15 patients with surgically corrected TOF. The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.
Key inclusion criteria (3 listed)
- D-TGA or Fallot-Tetralogy or Healthy person
- written informed consent
- Age >= 18 years
Key exclusion criteria (5 listed)
- Anaemia
- Pregnancy and breast feeding
- Diabetes mellitus
- Contraindications to stress testing (ergometry or adenosine)
- Known adverse reaction or hypersensitivity against V08DA (SonoVue) or its components or against adenosine
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 16 Jun 2015.
Related trials for D-Transposition of Great Arteries
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Recruiting
Effects Branch PA Stenting d-TGA, ToF and TA
Transposition of Great Vessels, Tetralogy of Fallot
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.
Christian Seiler, Prof. principal investigator
University Hospital Berne, Switzerland
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 D-Transposition of Great Arteries and Tetralogy of Fallot, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 5 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 16 Jun 2015. 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 Switzerland. 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 16 Jun 2015.