Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697736
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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).

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 or disease Intervention/treatment Phase
Systemic Scleroderma Procedure: Echocardiography with myocardial tissular Doppler mode Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697736

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

Responsible Party: Hospices Civils de Lyon Identifier: NCT00697736     History of Changes
Other Study ID Numbers: 2005.392
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Hospices Civils de Lyon:
Systemic Scleroderma

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