NCT00617487

Brief Summary

The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

10.3 years

First QC Date

February 6, 2008

Last Update Submit

March 6, 2018

Conditions

Systemic SclerosisPulmonary Arterial Hypertension

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with systemic sclerosis

You may qualify if:

  • Patients with systemic sclerosis according to LeRoy criteria

You may not qualify if:

  • Pregnancy
  • Significant valvular disease
  • Low left ventricular function upon echocardiography (ejection fraction\<55%)
  • History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Foundation Policlinico S. Matteo

Pavia, PV, 27100, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, PV, 27100, Italy

Location

Related Publications (1)

  • Cavagna L, Caporali R, Klersy C, Ghio S, Albertini R, Scelsi L, Moratti R, Bonino C, Montecucco C. Comparison of brain natriuretic peptide (BNP) and NT-proBNP in screening for pulmonary arterial hypertension in patients with systemic sclerosis. J Rheumatol. 2010 Oct;37(10):2064-70. doi: 10.3899/jrheum.090997. Epub 2010 Jul 15.

    PMID: 20634241DERIVED

MeSH Terms

Conditions

Scleroderma, SystemicPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefano Ghio, MD

    IRCCS Foundation Policlinico S. Matteo, Cardiology

    STUDY DIRECTOR

  • Lorenzo Cavagna, MD

    University and IRCCS Foundation Policlinico S. Matteo, Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dept. of Rheumatology

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2018

Study Completion

January 1, 2020

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

IT(2)