Systemic SclerodermaHTAP-SCLERONCT00697736
Cardiac Repercussion of Systemic Sclerodermias
A study testing Echocardiography with myocardial tissular Doppler mode in people with Systemic Scleroderma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- Echocardiography with myocardial tissular Doppler mode
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Dec 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 75 years
- Having a maximum speed of IT < 2.8 m/sec.
- Having read and understood the information note and having signed the informed consent form.
- And :
- Either carrying a systemic sclerodermia satisfying the criteria of American College of Rheumatology (the presence of a major criteria or two minor criterias is required for the systemic diagnosis of sclerodermia):
- Major criteria: proximal sclerodermia defined by a bilateral cutaneous sclerosis extending beyond the metacarpophalangeal and metatarsophalangeal joint.
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- Minor criteria: pulpar sclerodactylia, pulpar canker or scars, pulmonary fibrosis on thoracic radiography.
- Or presenting CREST syndrome, with at least 4 of the 5 following criterias :
- subcutaneous calcinosis,
- syndrome of Raynaud,
- attack oesophagienne,
- sclerodactylia,
- telangiectasis.
Who cannot join
- Over 75 years
- Having a maximum speed of TI > 2.8 m/sec.
- Patient affected by a connectivitis other than a sclerodermia : mixed connectivity, disseminated erythematous lupus, inflammatory idiopathic myopathy, rheumatoïd polyarthritis.
- Patient carrying a sclerodermia complicated by:
- renal failure (clearance > 30 ml - Cockraft)
- recent heart failure (< 2 months)
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- cardiac valvular attack, dilated, hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, chronic pulmonary heart or antecedent of myocarditis
- Coronaropathy objectified by stenosis or simple coronary irregularities on the coronarography or antecedent of myocardial infarction
- Chronic respiratory handicap with another origin than sclerodermia
- Unsigned informed consent form
- Patient with mental or psychiatric disorders, unable or unwilling to comply with protocol requirements.
- Patient treated with intraveinous derived of prostacyclin within 1 month before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT).
In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques.
Read more
So, the analysis of the right ventricular function appears capital, because:
- it is recognized like an essential determinant of the symptoms and effort capacity,
- its prevalence, physiopathology and prognostic values remain unknown in this pathology,
- its interest in the starting of the treatment remains to be specified.
The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT:
- the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode,
- the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise.
- the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period.
This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.
- Conditions
- Systemic Scleroderma
- Being tested
- Echocardiography with myocardial tissular Doppler mode
- Keywords
- Systemic Scleroderma, Echocardiography
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography with myocardial tissular Doppler modeProcedure or surgery
Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the incidence of right ventricular dysfonction evaluated by analysis of the regional myocardic function with myocardial tissular Doppler mode
Measured: each year for 5 years
Secondary outcomes (2)
To define the potential place of new regional myocardic function markers in the evaluation of the cardiac repercussion of systemic scleroderma and to correlate these markers with clinical, functional and hemodynamic parameters.
Measured: each year for five years
To detect an eventual prognostic role of regional myocardic function parameters which could allow to an earlier screening of the patients being able to receive a pulmonary vasodilator treatment before the rest PAHT occurrence .
Measured: each year for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2014
- Study completionDec 2014
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 Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697736
- Sponsor's protocol ID
- 2005.392
- Acronym
- HTAP-SCLERO
- Status last verified
- Nov 2015
- First submitted
- 12 Jun 2008
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thuny F, Lovric D, Schnell F, Bergerot C, Ernande L, Cottin V, Derumeaux G, Croisille P. Quantification of myocardial extracellular volume fraction with cardiac MR imaging for early detection of left ventricle involvement in systemic sclerosis. Radiology. 2014 May;271(2):373-80. doi: 10.1148/radiol.13131280. Epub 2014 Jan 15.
PubMed 24475856
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.
- ClinicalTrials.gov ID
- NCT00697736
- Acronym / sponsor ID
- HTAP-SCLERO / 2005.392
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jun 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.
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT).
In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques.
So, the analysis of the right ventricular function appears capital, because:
- it is recognized like an essential determinant of the symptoms and effort capacity,
- its prevalence, physiopathology and prognostic values remain unknown in this pathology,
- its interest in the starting of the treatment remains to be specified.
The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT:
- the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode,
- the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise.
- the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period.
This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age between 18 years and 75 years
- Having a maximum speed of IT < 2.8 m/sec.
- Having read and understood the information note and having signed the informed consent form.
- And :
Key exclusion criteria (12 listed)
- Over 75 years
- Having a maximum speed of TI > 2.8 m/sec.
- Patient affected by a connectivitis other than a sclerodermia : mixed connectivity, disseminated erythematous lupus, inflammatory idiopathic myopathy, rheumatoïd polyarthritis.
- Patient carrying a sclerodermia complicated by:
- renal failure (clearance > 30 ml - Cockraft)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography with myocardial tissular Doppler modeEchocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer | Procedure or surgery | – |
Primary outcome
To measure the incidence of right ventricular dysfonction evaluated by analysis of the regional myocardic function with myocardial tissular Doppler mode
Time frame: each year for 5 years
2 secondary outcomes
To define the potential place of new regional myocardic function markers in the evaluation of the cardiac repercussion of systemic scleroderma and to correlate these markers with clinical, functional and hemodynamic parameters.
Time frame: each year for five years
To detect an eventual prognostic role of regional myocardic function parameters which could allow to an earlier screening of the patients being able to receive a pulmonary vasodilator treatment before the rest PAHT occurrence .
Time frame: each year for five years
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 28 May 2019.
- Results publication: PubMed 24475856Thuny F, Lovric D, Schnell F, Bergerot C, Ernande L, Cottin V, Derumeaux G, Croisille P. Quantification of myocardial extracellular volume fraction with cardiac MR imaging for early detection of left ventricle involvement in systemic sclerosis. Radiology. 2014 May;271(2):373-80. doi: 10.1148/radiol.13131280. Epub 2014 Jan 15.
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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?
A study testing Echocardiography with myocardial tissular Doppler mode in people with Systemic Scleroderma, run by Hospices Civils de Lyon at 1 site in France.
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 13 inclusion and 12 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 28 May 2019. 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 France. 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?
To measure the incidence of right ventricular dysfonction evaluated by analysis of the regional myocardic function with myocardial tissular Doppler mode (time frame: each year for 5 years). 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 NCT00697736, 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 28 May 2019.