Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary HTN (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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension (CRAB-PH)

Acronym: CRAB-PH

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2020
First posted: Aug 19, 2016
Registry last updated: Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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