- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873039
Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary HTN (CRAB-PH) (CRAB-PH)
Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension (CRAB-PH)
Study Overview
Status
Conditions
Detailed Description
Pulmonary hypertension patients who choose to participate:
Written informed consent will be obtained for the study. Patients must sign the informed consent before participating in any study related procedures.
- All inclusion and exclusion criteria will be reviewed.
- Demographic history will be recorded.
- Vital signs will be performed.
- A medication history will be taken.
- A smoking history will be recorded.
- BNP levels will be measured as a part of usual care at PH visits.
- Ultrasonographic measurements will be performed at the clinic visit.
- Ultrasonographic measurements:
IVC Measurements
- Performed in the subcostal view in supine position.
- Images will be captured in a video format.
- Maximal IVC diameter 1 to 2 cm from the junction of the right atrium and the IVC at end-expiration just proximal to the junction of the hepatic veins. The IVC collapsibility index to give an estimate of RAP.
- Inspiratory collapse of > 50% or < 50% will be ascertained based on the measurements.
Jugular Vein Measurements
- Patient will be placed in 45° position
- Longitudinal images will be obtained of the right jugular vein.
- Location of tapering of the jugular vein is measured, and distance from the sternal angle is recorded as ultrasound-measured jugular venous pressure (JVP).
Clinical Worsening Outcomes
• At each visit during year 1, and then every 6 months for years 2-3, clinical worsening events will be captured. These events are defined as:
- Death
- PH-related hospitalization
- Lung transplant
- Atrial septostomy
- Functional Class worsening and step up in therapy
Study Timing
- Enrollment of patients for a period of 1 year. Subsequently, no more patients will be enrolled. Patients who are enrolled will be followed clinically without further study-related testing at their regular clinic visits after completion of year 1.
- All patients enrolled will have ultrasonographic measurements of IVC and jugular veins at each clinic visit for 1 year.
- Data collection regarding meeting clinical worsening end points and BNP levels will be collected at the regular clinic visits at year 2 and 3 of the study.
- If patients are lost to follow up at clinics (including year-1), telephone correspondence, social security database review or chart review at 6-month intervals will be performed to determine vital status and see if they have met any clinical worsening endpoints.
- Study will close after the final patient has completed 3-years of follow up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- University Medical Center - New Orleans
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18
- Clinical diagnosis of pulmonary hypertension
- BNP levels measured on day of clinic visit
Exclusion Criteria:
- Pregnant females
- Inability to lay flat for the ultra-sonographic measurements
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who show a relationship between inferior vena cava (IVC) measurements, eRAP and BNP using ultrasound.
Time Frame: 1 year
|
To accomplish this objective, ultrasonographic measurements of the IVC and jugular veins will be performed at each visit, which can be easily measured longitudinally to establish a relationship with BNP.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Clinical worsening
Time Frame: 2 years
|
Any outcome measure that indicates the patient is clinically worse than the previous visit will be considered in the assessment of time to clinical worsening. The 2 year follow-up period will assess:
These outcomes will all be used in the determination of disease progression. |
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthew R Lammi, MD, MSCR, Louisiana State University Health Sciences Center - New Orleans
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 9403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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