Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary HTN (CRAB-PH)
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | July 2016 |
| End Date: | July 2020 |
| Contact: | Matthew R Lammi, MD, MSCR |
| Email: | mlammi@lsuhsc.edu |
| Phone: | 1 (504) 568-4634 |
Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension (CRAB-PH)
Over the past decade, advancements in therapies available for pulmonary hypertension (PH)
have increased life expectancy for those who qualify and receive treatment. Yet,
prognostication of these patients has remained a clinical dilemma. The application of the
REVEAL registry predictive algorithm provides information about estimated 1-year survival but
since invasive measurements from a right heart catheterization cannot easily be repeated, it
is not feasible to continually use this longitudinally to assess the disease burden. Simple
tests such as BNP has been shown to be very clinically relevant in short -term and long term
prognostication and seems to correspond well to the right ventricular failure. Elevated right
atrial pressures, and its estimation via IVC measurements predict poor survivorship in a
recent retrospective analysis. As clinical measurement of jugular venous pressure is becoming
less reliable, we aim to bring point- of-care ultrasound to the outpatient setting. Point of
care ultrasound is widely used in the Emergency Department and Intensive Care Unit settings.
By measuring estimated right atrial pressure (eRAP) via Inferior Vena Cava (IVC) measurements
at outpatient clinic visits we aim to find a correlation with the existing and widely used
B-type Natriuretic Peptide (BNP), that is collected at each visit as a part of regular care.
These measurements can be followed longitudinally and may aid in prognostication. Data will
be collected over the period of 1 year at clinic visits. A composite endpoint (including
death, hospitalizations for PH, addition of new PH specific therapy after a stabilization
period of 3 months, lung transplant or atrial septostomy) will separately be collected. At
the end of the data collection period, clinical data only will be collected for a additional
2 years via phone correspondence, chart review or at regular PH clinic visits.
have increased life expectancy for those who qualify and receive treatment. Yet,
prognostication of these patients has remained a clinical dilemma. The application of the
REVEAL registry predictive algorithm provides information about estimated 1-year survival but
since invasive measurements from a right heart catheterization cannot easily be repeated, it
is not feasible to continually use this longitudinally to assess the disease burden. Simple
tests such as BNP has been shown to be very clinically relevant in short -term and long term
prognostication and seems to correspond well to the right ventricular failure. Elevated right
atrial pressures, and its estimation via IVC measurements predict poor survivorship in a
recent retrospective analysis. As clinical measurement of jugular venous pressure is becoming
less reliable, we aim to bring point- of-care ultrasound to the outpatient setting. Point of
care ultrasound is widely used in the Emergency Department and Intensive Care Unit settings.
By measuring estimated right atrial pressure (eRAP) via Inferior Vena Cava (IVC) measurements
at outpatient clinic visits we aim to find a correlation with the existing and widely used
B-type Natriuretic Peptide (BNP), that is collected at each visit as a part of regular care.
These measurements can be followed longitudinally and may aid in prognostication. Data will
be collected over the period of 1 year at clinic visits. A composite endpoint (including
death, hospitalizations for PH, addition of new PH specific therapy after a stabilization
period of 3 months, lung transplant or atrial septostomy) will separately be collected. At
the end of the data collection period, clinical data only will be collected for a additional
2 years via phone correspondence, chart review or at regular PH clinic visits.
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.
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.
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
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