Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)

May 23, 2019 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • BRON Cedex, France, 69 677
        • Hopital Louis Pradel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
each year for 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
each year for five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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