Registry of Sarcoidosis Associated Pulmonary Hypertension... | NCT01467791

Studies
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

NCT01467791

Sponsor

University of Cincinnati

Status

Unknown status

Last Update Posted

Dec 8, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Sarcoidosis
Pulmonary Hypertension

Interventions

Observation

Countries

United States

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

Dec 2015

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

Nov 2011

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Nov 4, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 9, 2011Estimated

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

Dec 4, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Name	Class
The Cleveland Clinic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Registry to follow patients with sarcoidosis associated pulmonary hypertension

Detailed Description

This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites.

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

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		All patients with sarcoidosis associated pulmonary hypertension	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observe patients	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Mortality during time of study	4 years

Secondary Outcomes

Measure	Description	Time Frame
Disease management	Examine initial and follow up management	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with sarcoidosis as defined by the ATS/WASOG statement
Patients with pulmonary hypertension as confirmed by right heart catheterization
Patients willing to provide written informed consent

Exclusion Criteria:

Unwillingness to provide assurance that they will complete the follow up visits for the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with sarcoidosis associated pulmonary hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert P Baughman, MD	Contact	513-584-5225		bob.baughman@uc.edu
Rebecca Ingledue	Contact	513-584-6252

Overall Officials

Name	Affiliation	Role
Robert P Baughman, MD	University of Cincinnati	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati	Recruiting	Cincinnati	Ohio	45267	United States

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided