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Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)

Primary Purpose

Systemic Scleroderma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Echocardiography with myocardial tissular Doppler mode

About this trial

This is an interventional diagnostic trial for Systemic Scleroderma focused on measuring Systemic Scleroderma, Echocardiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Louis Pradel

Outcomes

Primary Outcome Measures

To measure the incidence of right ventricular dysfonction evaluated by analysis of the regional myocardic function with myocardial tissular Doppler mode

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.

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 .

Full Information

NCT ID

NCT00697736

First Posted

June 12, 2008

Last Updated

May 23, 2019

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00697736

Brief Title

Cardiac Repercussion of Systemic Sclerodermias

Acronym

HTAP-SCLERO

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Scleroderma

Keywords

Systemic Scleroderma, Echocardiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Echocardiography with myocardial tissular Doppler mode

Intervention Description

Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

each year for five years

Title

Time Frame

each year for five years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Hôpital Louis Pradel

City

BRON Cedex

ZIP/Postal Code

69 677

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24475856

Citation

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.

Results Reference

result

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Cardiac Repercussion of Systemic Sclerodermias

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