- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467791
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH) (RESAPH)
December 4, 2015 updated by: Robert P Baughman, University of Cincinnati
Registry to follow patients with sarcoidosis associated pulmonary hypertension
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca Ingledue
- Phone Number: 513-584-6252
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- Recruiting
- University of Cincinnati
-
Contact:
- Rebecca Ingledue
- Phone Number: 513-584-6252
- Email: ingledra@ucmail.uc.edu
-
Principal Investigator:
- Robert P Baughman, MD
-
Sub-Investigator:
- Peter Engel, MD
-
-
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 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with sarcoidosis associated pulmonary hypertension
Description
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
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
All patients with sarcoidosis associated pulmonary hypertension
|
Observe patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 4 years
|
Mortality during time of study
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease management
Time Frame: 4 years
|
Examine initial and follow up management
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
November 1, 2011
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
November 4, 2011
First Submitted That Met QC Criteria
November 8, 2011
First Posted (Estimate)
November 9, 2011
Study Record Updates
Last Update Posted (Estimate)
December 8, 2015
Last Update Submitted That Met QC Criteria
December 4, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESAPH 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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