Pulmonary HypertensionCRAB-PHNCT02873039
Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary HTN (CRAB-PH)
An observational study of Pulmonary Hypertension, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the University Medical Center with a clinical diagnosis of pulmonary hypertension.
Who may be able to join
- Age > 18
- Clinical diagnosis of pulmonary hypertension
- BNP levels measured on day of clinic visit
Who cannot join
- Pregnant females
- Inability to lay flat for the ultra-sonographic measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center - New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who show a relationship between inferior vena cava (IVC) measurements, eRAP and BNP using ultrasound.
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.
Measured: 1 year
Secondary outcomes (1)
Time to Clinical worsening
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2018
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Matthew R Lammi, MD, MSCR, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873039
- Sponsor's protocol ID
- IRB 9403
- Acronym
- CRAB-PH
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2016
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be made available.
Publications
Samant S, Tran HV, Uddo RB, deBoisblanc BP, Saketkoo LA, Saito S, Helmcke FR, Lammi MR. Use of Handheld Ultrasound to Estimate Right Atrial Pressure in a Pulmonary Hypertension Clinic. Ann Am Thorac Soc. 2022 Feb;19(2):179-185. doi: 10.1513/AnnalsATS.202101-092OC.
PubMed 34214012
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension (CRAB-PH)
- ClinicalTrials.gov ID
- NCT02873039
- Acronym / sponsor ID
- CRAB-PH / IRB 9403
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the University Medical Center with a clinical diagnosis of pulmonary hypertension.
Key inclusion criteria (3 listed)
- Age > 18
- Clinical diagnosis of pulmonary hypertension
- BNP levels measured on day of clinic visit
Key exclusion criteria (2 listed)
- Pregnant females
- Inability to lay flat for the ultra-sonographic measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Time to Clinical worsening
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 34214012Samant S, Tran HV, Uddo RB, deBoisblanc BP, Saketkoo LA, Saito S, Helmcke FR, Lammi MR. Use of Handheld Ultrasound to Estimate Right Atrial Pressure in a Pulmonary Hypertension Clinic. Ann Am Thorac Soc. 2022 Feb;19(2):179-185. doi: 10.1513/AnnalsATS.202101-092OC.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew R Lammi, MD, MSCR principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who show a relationship between inferior vena cava (IVC) measurements, eRAP and BNP using ultrasound. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02873039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.