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

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ClinicalTrials.gov Identifier: NCT02873039
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
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.

Condition or disease
Pulmonary Hypertension

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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:

    1. All-cause death
    2. Need for atrial septostomy
    3. Need for lung transplant
    4. Hospitalization for PH
    5. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present to the University Medical Center with a clinical diagnosis of pulmonary hypertension.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Louisiana
University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Matthew R Lammi, MD, MSCR Louisiana State University Health Sciences Center - New Orleans
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Lammi, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02873039    
Other Study ID Numbers: IRB 9403
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data (IPD) will not be made available.
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases