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 Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
        • 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
Other: Observation
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

University of Cincinnati

Collaborators

The Cleveland Clinic

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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