SarcoidosisRESAPHNCT01467791
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
An observational study of Sarcoidosis and Pulmonary Hypertension, run by University of Cincinnati at 1 site in United States.
Trial summary
Registry to follow patients with sarcoidosis associated pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sarcoidosis, Pulmonary Hypertension
- What is being tested?
- Observation
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sarcoidosis associated pulmonary hypertension
Who may be able to join
- 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
Who cannot join
- Unwillingness to provide assurance that they will complete the follow up visits for the study
Trial locations and contacts
1 site in 1 country.
Rebecca Ingledue contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Rebecca Ingledue, 513-584-6252, ingledra@ucmail.uc.edu
Robert P Baughman, MD
About this study
Registry to follow patients with sarcoidosis associated pulmonary hypertension
Read the 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.
- Conditions
- Sarcoidosis, Pulmonary Hypertension
- Being tested
- Observation
- Keywords
- ambrisentan, Bosentan, Iloprost
- Medical subject headings
- Sarcoidosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observe patients
| Study group | Role | What they receive |
|---|---|---|
| Patients | All patients with sarcoidosis associated pulmonary hypertension Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Mortality during time of study
Measured: 4 years
Secondary outcomes (1)
Disease management
Examine initial and follow up management
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert P Baughman, MD, Study chair, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467791
- Sponsor's protocol ID
- RESAPH 1
- Acronym
- RESAPH
- Status last verified
- Dec 2015
- First submitted
- 4 Nov 2011
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
- ClinicalTrials.gov ID
- NCT01467791
- Acronym / sponsor ID
- RESAPH / RESAPH 1
- Conditions
- Sarcoidosis, Pulmonary Hypertension
- Keywords
- ambrisentan, Bosentan, Iloprost
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Nov 2011
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registry to follow patients with sarcoidosis associated pulmonary hypertension
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: ObservationAll patients with sarcoidosis associated pulmonary hypertension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sarcoidosis associated pulmonary hypertension
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unwillingness to provide assurance that they will complete the follow up visits for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObserve patients | Other | Patients |
Primary outcome
Survival
Time frame: 4 years
Mortality during time of study
1 secondary outcome
Disease management
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Ingledue contact
Robert P Baughman, MD study chair
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Pulmonary Hypertension, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert P Baughman, MD (513-584-5225, bob.baughman@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.