Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00697736
First received: June 12, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Systemic Scleroderma
Procedure: Echocardiography with myocardial tissular Doppler mode

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: March 2007
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Echocardiography with myocardial tissular Doppler mode
    Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
      • 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.

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697736

Locations
France
Hôpital Louis Pradel
BRON Cedex, France, 69 677
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00697736     History of Changes
Other Study ID Numbers: 2005.392
Study First Received: June 12, 2008
Last Updated: May 21, 2014
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Systemic Scleroderma
Echocardiography

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014