Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary HTN (CRAB-PH) (CRAB-PH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02873039|
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : September 10, 2021
|Condition or disease|
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:
- 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:
- PH-related hospitalization
- Lung transplant
- Atrial septostomy
- Functional Class worsening and step up in therapy
- 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 :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension (CRAB-PH)|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||July 2020|
- 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.
- 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:
- All-cause death
- Need for atrial septostomy
- Need for lung transplant
- Hospitalization for PH
- Worsening functional class (or no improvement from functional class 4) and need for additional PH therapies after a period of initial clinical stabilization of 3 months.
These outcomes will all be used in the determination of disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873039
|United States, Louisiana|
|University Medical Center - New Orleans|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Matthew R Lammi, MD, MSCR||Louisiana State University Health Sciences Center - New Orleans|