NCT01467791

Brief Summary

Registry to follow patients with sarcoidosis associated pulmonary hypertension

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

5.2 years

First QC Date

November 4, 2011

Last Update Submit

December 4, 2015

Conditions

SarcoidosisPulmonary Hypertension

Keywords

ambrisentanBosentanIloprost

Outcome Measures

Primary Outcomes (1)

  • Survival

    Mortality during time of study

    4 years

Secondary Outcomes (1)

  • Disease management

    4 years

Study Arms (1)

Patients

All patients with sarcoidosis associated pulmonary hypertension

Other: Observation

Interventions

ObservationOTHER

Observe patients

Patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sarcoidosis associated pulmonary hypertension

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

SarcoidosisHypertension, Pulmonary

Interventions

Observation

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Robert P Baughman, MD

    University of Cincinnati

    STUDY CHAIR

Central Study Contacts

Robert P Baughman, MD

CONTACT

513-584-5225bob.baughman@uc.edu

Rebecca Ingledue

CONTACT

513-584-6252

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

US(1)