Non-Invasive Diagnostic and Functional Evaluation of Card... | NCT00453752

Studies
Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis

NCT00453752

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

Mar 29, 2007Estimated

Enrollment

100

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Apr 2010Estimated

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2007

Last Update Posted Date

Mar 29, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.

Detailed Description

Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

Cardiovascular disorders other than pulmonary hypertension
Significant pulmonary function abnormalities
Impaired renal function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ciurzyński Michał, M.D, Ph.D	Contact	+48 22 502 11 44		mciurzyn@amwaw.edu.pl
Piotr Pruszczyk, M.D, Ph.D.	Contact	+48 22 501 11 44		ppruszczyk@amwaw.edu.pl

Overall Officials

Name	Affiliation	Role
Michał Ciurzyński, M.D., Ph.D	Medical University of Warsaw	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michał Ciurzyński	Recruiting	Warsaw	Lindleya 4	02-005	Poland

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided