Pulmonary StenosisNCT00266175
Pulmonary Arteriopathy-Diagnostics and Therapy
An observational study of Pulmonary Stenosis, run by Competence Network for Congenital Heart Defects at 5 sites in Germany.
Trial summary
Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are frequently found in connection with congenital heart defects or malformation syndromes. The resulting increase of afterload represents a serious pressure load for the right ventricle. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pulmonary Stenosis
- How many people
- 53 participants
- Where
- 5 sitesGermany
- Study dates
- May 2005to Jul 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with native or postoperative peripheral pulmonary stenoses (PPS; any stenoses that are located distally to the RVOT). Definition of PPS: 40% lumen constriction, or 30% constriction if volume stress is also present. Informed consent of the patient or his/her legal representative is given after instruction. -
Who cannot join
- Patients unable to undergo MRI or spiroergometry for physical or psychological reasons.
- Pregnant or nursing patients. Patients affected by other clinically relevant diseases (malignant tumours, infectious diseases, metabolic disorders etc.). Patients with known intolerance of contrast media. Patients with syndromal diseases such as Alagille's syndrome, rubella embryopathy or elfin face syndrome. -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, D-32545
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, D-13353
Medizinische Hochschule Hannover
Hanover, Lower Saxony, D-30625
Universitätsklinikum des Saarlandes
Homburg, Saarland, D-66421
Deutsches Kinderherzzentrum
Sankt Augustin, North Rhine-Westphalia, D-53757
About this study
Official title: Pulmonary Arteriopathy; Evaluation of Invasive Treatments of Peripheral Pulmonary Stenosis in Terms of Right Ventricular Function and Patient Exercise Tolerance
Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are frequently found in connection with congenital heart defects or malformation syndromes. The resulting increase of afterload represents a serious pressure load for the right ventricle. Depending on the number and severity of the stenoses, gradual functional right ventricular failure is to be expected. Due to limited clinical experience, there has not yet been a consensus concerning the indications for the different therapeutic strategies (balloon dilatation, stent implantation, surgical dilatation techniques). Up to now, only few investigators in few centres use stents as therapy. Therefore, systematic multicenter investigations assessing larger groups of patients undergoing this procedure are not yet available. The same applies to other novel dilatation techniques, such as the use of the "cutting balloon" as therapy for rigid valve stenoses.
By comparing and analysing different invasive forms of treatment (balloon dilatation, stent implantation and surgery), we expect to achieve an optimisation of therapy.
In the study, the outcomes of different strategies as practiced now in German cardiological centers will be compared and the main factors influencing the results will be determined. On the basis of a standardized investigation before and one year after the intervention, these comparisons with respect to the reduction of stenosis and corresponding changes of right ventricular functional and anatomical changes are carried out correcting for known confounders. The assessment of the different included invasive and non-invasive diagnostical procedures with respect to their ability to detect pathological findings and their changes as result of the treatment is an important secondary target of the study.
Read the detailed description
For patients with untreated peripheral pulmonary stenoses, the course of disease is characterised by a chronic pressure load of the right ventricle. In the medium to long term this can lead to right heart failure and cardiac arrhythmia unresponsive to therapy. The probability of these events as well as the time of their occurrence depends on the severity of the stenoses, the duration of stress and a possible additional volume load. Within the scope of the prospective study introduced here, we intend to characterise the stenoses with respect to degree and type and to document the treatment success in terms of decrease of afterload of the right ventricle. In this context, imaging and catheter-based methods as well as respective functional analyses are to be used to provide evidence of a reduction or neutralisation of the pulmonary artery stenoses.
Accordingly, the following questions, or corresponding objectives, can be identified as the base for the conduct of this clinical trial:
- Morphological and functional categorisation of the angiostenoses and standardisation of the diagnostic procedures. For this purpose, the quantitative criteria for both the morphological degree of stenosis (lumen constriction) and the functional degree of stenosis (pressure gradient) are established by means of cardiac catheterisation and angiography. Non-invasive imaging methods, which have as yet been restricted primarily to echocardiography, are complemented by the method of spin angiography. Compared to conventional angiography, this has the advantage of being less invasive and not involving radiation exposure.
- On the strength of past experience, the implantation of stents can be viewed as a very promising approach to a treatment with lasting effectiveness of pulmonary artery stenoses. The stents have the advantage of high radial forces that can be offset against the elastic recoil of the vessels occurring after sole dilatation. Furthermore, constrictions that are caused by either kinking of vessels or their compression by neighbouring structures can be dilated sufficiently by the use of stents.
- With respect to the interconnectedness of all the projects of the Competence Network for Congenital Heart Defects, one essential aspect is the standardisation of diagnostic methods of evaluating right ventricular function. The data obtained during the study are to provide the basis for the development of diagnostic guidelines.
- Concerning evaluation, particular attention is paid to the patients' self-assessment with respect to their exercise tolerance. In this context, it is a matter of interest to what degree the patients' subjective maximum stress and therefore their quality of life correlate with the objective measurement parameters. The anticipated results are of direct clinical significance for the patients, as they aim at medium to long-term relief of the right ventricle, which may effect a decrease in morbidity and therefore an improvement of the quality of life. This is of particular importance with regard to the fact that there will be a continuously increasing number of patients with congenital heart defects reaching adulthood.
- Conditions
- Pulmonary Stenosis
- Keywords
- Pulmonary heart disease, Pulmonary hypertension, Stent implantation, Balloon dilatation, Surgery
- Medical subject headings
- Pulmonary Valve Stenosis, Pulmonary Heart Disease, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure:
To assess the efficacy of the administered therapy, both the ectasia of the stenosed vessels in
relation to the target diameter and the reduction of the pressure gradient in the stenosed vessel
are indicated in percent. An evaluation of the therapeutic success takes place after twelve months.
Definition of the primary target of therapy:
Morphometric:
• Expansion of the peripheral pulmonary artery stenosis to at least 80% of the vascular
lumen.
Manometric:
• Gradient reduction over the stenosis of at least 50%.
• Reduction in right ventricular systolic pressure, indicated by a reduced ratio of systolic
pressure of LV to RV. In this context, there is no definition in terms of a primary target,
as right ventricular pressure reduction depends on a variety of parameters (such as
number of stenoses of the entire peripheral pulmonary vasculature, potential
additional volume load and right ventricular overall function).
Secondary outcomes (9)
Secondary outcome measures:
The improvement of the right ventricular systolic and diastolic function as well as reduction of
ventricle size and of tricuspid valve incompetence are quantified by means of echocardiography,
angiography and, where required, nuclear magnetic resonance tomography.
An improvement in capability/quality of life is assessed by means of bicycle ergometer
examinations as well as the SF-36 (New England Hospital Inc.) and KINDL questionnaires
(Ravens-Sieberer & Bullinger) for adults and children respectively.
In assessing the organ-related outcome measures, the different diagnostic imaging methods are
compared with each other.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startMay 2005
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary StenosisStudies 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
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Competence Network for Congenital Heart Defects
- Sponsor type
- Other government
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Martin Schneider, MD, Principal investigator, Deutsches Kinderherzzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266175
- Sponsor's protocol ID
- MP 1
- Other IDs
- 01G10210
- Status last verified
- Oct 2008
- First submitted
- 15 Dec 2005
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Arteriopathy; Evaluation of Invasive Treatments of Peripheral Pulmonary Stenosis in Terms of Right Ventricular Function and Patient Exercise Tolerance
- ClinicalTrials.gov ID
- NCT00266175
- Acronym / sponsor ID
- MP 1
- Conditions
- Pulmonary Stenosis
- Keywords
- Pulmonary heart disease, Pulmonary hypertension, Stent implantation, Balloon dilatation, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Competence Network for Congenital Heart DefectsOther government
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- May 2005
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Dec 2005 (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.
Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are frequently found in connection with congenital heart defects or malformation syndromes. The resulting increase of afterload represents a serious pressure load for the right ventricle. Depending on the number and severity of the stenoses, gradual functional right ventricular failure is to be expected. Due to limited clinical experience, there has not yet been a consensus concerning the indications for the different therapeutic strategies (balloon dilatation, stent implantation, surgical dilatation techniques). Up to now, only few investigators in few centres use stents as therapy. Therefore, systematic multicenter investigations assessing larger groups of patients undergoing this procedure are not yet available. The same applies to other novel dilatation techniques, such as the use of the "cutting balloon" as therapy for rigid valve stenoses.
By comparing and analysing different invasive forms of treatment (balloon dilatation, stent implantation and surgery), we expect to achieve an optimisation of therapy.
In the study, the outcomes of different strategies as practiced now in German cardiological centers will be compared and the main factors influencing the results will be determined. On the basis of a standardized investigation before and one year after the intervention, these comparisons with respect to the reduction of stenosis and corresponding changes of right ventricular functional and anatomical changes are carried out correcting for known confounders. The assessment of the different included invasive and non-invasive diagnostical procedures with respect to their ability to detect pathological findings and their changes as result of the treatment is an important secondary target of the study.
Detailed description
For patients with untreated peripheral pulmonary stenoses, the course of disease is characterised by a chronic pressure load of the right ventricle. In the medium to long term this can lead to right heart failure and cardiac arrhythmia unresponsive to therapy. The probability of these events as well as the time of their occurrence depends on the severity of the stenoses, the duration of stress and a possible additional volume load. Within the scope of the prospective study introduced here, we intend to characterise the stenoses with respect to degree and type and to document the treatment success in terms of decrease of afterload of the right ventricle. In this context, imaging and catheter-based methods as well as respective functional analyses are to be used to provide evidence of a reduction or neutralisation of the pulmonary artery stenoses.
Accordingly, the following questions, or corresponding objectives, can be identified as the base for the conduct of this clinical trial:
- Morphological and functional categorisation of the angiostenoses and standardisation of the diagnostic procedures. For this purpose, the quantitative criteria for both the morphological degree of stenosis (lumen constriction) and the functional degree of stenosis (pressure gradient) are established by means of cardiac catheterisation and angiography. Non-invasive imaging methods, which have as yet been restricted primarily to echocardiography, are complemented by the method of spin angiography. Compared to conventional angiography, this has the advantage of being less invasive and not involving radiation exposure.
- On the strength of past experience, the implantation of stents can be viewed as a very promising approach to a treatment with lasting effectiveness of pulmonary artery stenoses. The stents have the advantage of high radial forces that can be offset against the elastic recoil of the vessels occurring after sole dilatation. Furthermore, constrictions that are caused by either kinking of vessels or their compression by neighbouring structures can be dilated sufficiently by the use of stents.
- With respect to the interconnectedness of all the projects of the Competence Network for Congenital Heart Defects, one essential aspect is the standardisation of diagnostic methods of evaluating right ventricular function. The data obtained during the study are to provide the basis for the development of diagnostic guidelines.
- Concerning evaluation, particular attention is paid to the patients' self-assessment with respect to their exercise tolerance. In this context, it is a matter of interest to what degree the patients' subjective maximum stress and therefore their quality of life correlate with the objective measurement parameters. The anticipated results are of direct clinical significance for the patients, as they aim at medium to long-term relief of the right ventricle, which may effect a decrease in morbidity and therefore an improvement of the quality of life. This is of particular importance with regard to the fact that there will be a continuously increasing number of patients with congenital heart defects reaching adulthood.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with native or postoperative peripheral pulmonary stenoses (PPS; any stenoses that are located distally to the RVOT). Definition of PPS: 40% lumen constriction, or 30% constriction if volume stress is also present. Informed consent of the patient or his/her legal representative is given after instruction. -
Key exclusion criteria (2 listed)
- Patients unable to undergo MRI or spiroergometry for physical or psychological reasons.
- Pregnant or nursing patients. Patients affected by other clinically relevant diseases (malignant tumours, infectious diseases, metabolic disorders etc.). Patients with known intolerance of contrast media. Patients with syndromal diseases such as Alagille's syndrome, rubella embryopathy or elfin face syndrome. -
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
Primary outcome measure:
To assess the efficacy of the administered therapy, both the ectasia of the stenosed vessels in
relation to the target diameter and the reduction of the pressure gradient in the stenosed vessel
are indicated in percent. An evaluation of the therapeutic success takes place after twelve months.
Definition of the primary target of therapy:
Morphometric:
• Expansion of the peripheral pulmonary artery stenosis to at least 80% of the vascular
lumen.
Manometric:
• Gradient reduction over the stenosis of at least 50%.
• Reduction in right ventricular systolic pressure, indicated by a reduced ratio of systolic
pressure of LV to RV. In this context, there is no definition in terms of a primary target,
as right ventricular pressure reduction depends on a variety of parameters (such as
number of stenoses of the entire peripheral pulmonary vasculature, potential
additional volume load and right ventricular overall function).
9 secondary outcomes
Secondary outcome measures:
The improvement of the right ventricular systolic and diastolic function as well as reduction of
ventricle size and of tricuspid valve incompetence are quantified by means of echocardiography,
angiography and, where required, nuclear magnetic resonance tomography.
An improvement in capability/quality of life is assessed by means of bicycle ergometer
examinations as well as the SF-36 (New England Hospital Inc.) and KINDL questionnaires
(Ravens-Sieberer & Bullinger) for adults and children respectively.
In assessing the organ-related outcome measures, the different diagnostic imaging methods are
compared with each other.
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 15 Oct 2008.
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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.
Martin Schneider, MD principal investigator
Deutsches Kinderherzzentrum
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Stenosis, run by Competence Network for Congenital Heart Defects at 5 sites 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 2 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 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does the primary outcome measure?
Primary outcome measure:. The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Oct 2008.