Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Cincinnati
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01467791
First received: November 4, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

Registry to follow patients with sarcoidosis associated pulmonary hypertension


Condition Intervention
Sarcoidosis
Pulmonary Hypertension
Other: Observation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Mortality during time of study


Secondary Outcome Measures:
  • Disease management [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Examine initial and follow up management


Biospecimen Retention:   Samples Without DNA

Serum samples


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
All patients with sarcoidosis associated pulmonary hypertension
Other: Observation
Observe patients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with sarcoidosis associated pulmonary hypertension

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467791

Contacts
Contact: Robert P Baughman, MD 513-584-5225 bob.baughman@uc.edu
Contact: Rebecca Ingledue 513-584-6252

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Rebecca Ingledue    513-584-6252    ingledra@ucmail.uc.edu   
Principal Investigator: Robert P Baughman, MD         
Sub-Investigator: Peter Engel, MD         
Sponsors and Collaborators
University of Cincinnati
The Cleveland Clinic
Investigators
Study Chair: Robert P Baughman, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01467791     History of Changes
Other Study ID Numbers: RESAPH 1
Study First Received: November 4, 2011
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
ambrisentan
Bosentan
Iloprost

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014