Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Pulmonary Hypertension Clinical Trial

— RESAPH  

Official title:

Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01467791
• Other study ID #: RESAPH 1
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2011
• Last updated: December 4, 2015
• Start date: November 2011
• Est. completion date: January 2018

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: Robert P Baughman, MD
• Phone: 513-584-5225
• Email: bob.baughman[@]uc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Registry to follow patients with sarcoidosis associated pulmonary hypertension

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sarcoidosis

Intervention

Other:
• Observation
Observe patients

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Mortality during time of study	4 years	No
Secondary	Disease management	Examine initial and follow up management	4 years	No