Pulmonary HypertensionNCT03089164
Postural Changes During Right Heart Catheterization
An observational study of Pulmonary Hypertension and Right Heart Failure Due to Pulmonary Hypertension, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Hemodynamic measurements obtained during pulmonary artery catheterization are essential for the diagnosis and classification of pulmonary hypertension. Traditionally, right heart catheterization (RHC) is done in the supine position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Right Heart Failure Due to Pulmonary Hypertension
- What is being tested?
- Right heart catheterization
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 29 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be a cohort of patients referred for right heart catheterization for workup of pulmonary arterial hypertension.
Who may be able to join
- All patients that are 18 years or older regardless of gender or race,
- are referred for RHC for evaluation of possible Pulmonary Arterial Hypertension (PAH)
- provide informed consent
Who cannot join
- Inability to obtain pulmonary artery pressure or PCWP
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Assessing the Influence of Postural Changes During Right Heart Catheterization for the Evaluation of Pulmonary Hypertension
Hemodynamic measurements obtained during pulmonary artery catheterization are essential for the diagnosis and classification of pulmonary hypertension. Traditionally, right heart catheterization (RHC) is done in the supine position. Cardiac output is known to change significantly based on position, due to the effects of gravity on venous return. There has not been a systematic investigation into these postural effects on pulmonary arterial pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to study the differences in measurements obtained during RHC when the patient is supine, seated, and standing.
Read the detailed description
The investigators also plan a prospective study of patients referred for pulmonary artery catheterization at the UNC cardiac catheterization lab for evaluation of known or suspected pulmonary hypertension. The purpose of this portion of the study is to evaluate the degree to which digital reading of pulmonary artery pressure (PAP) and pulmonary capillary wedge pressure (PCWP) impact the diagnosis and classification of pulmonary hypertension specifically in patients being evaluated for pulmonary hypertension while being tested in the supine, sitting and standing positions.
The investigators will identify 60 patients referred for right heart catheterization to evaluate known or suspected pulmonary hypertension. Patients will have right heart catheterization performed by the clinician that was planning on performing the procedure and a pulmonary hypertension specialist in the Division of Pulmonary and Critical Care Medicine or Division of Cardiology. After informed consent is obtained, the subject will be prepped and draped per protocol in the UNC Cath lab. Their internal jugular vein will be visualized by ultrasound and accessed with a pulmonary artery catheter using standard procedure which also uses fluoroscopy to ensure correct placement of the catheter. Once pressure measurements are obtained from the cardiac chambers and pulmonary arteries, the catheter will be secured into place with tegaderm to allow for mobilization of the patient. The patient will then be asked to sit up on the side of the cath table and the pressure transducer will be re-calibrated to be at the level of the patient's right atrium. Repeat measurements will be obtained of the pulmonary artery and PCWP in this position. After, the patient will be asked to stand up and the pressure transducer once again re-calibrated to estimate the level of the right atrium; new measurements will be obtained in the standing position. Each position will be maintained for 5 minutes before measurements are taken. The supine position measurement will be used for clinical decision making purposes as per usual. The investigators will collect each measurement over at least 10 cardiac cycles and use the mean end-expiratory values to ensure precision.
Once all measurements are obtained, the patient will be asked to return to the supine position. The tegaderm will be released and the catheter removed during sustained expiration maneuver per standard protocol.
No sedation will be administered to the patients.
No further contact will be done with the study subject for the purpose of this research trial.
- Being tested
- Right heart catheterization
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right heart catheterizationDiagnostic test
Each patient will have variables measured supine, sitting and standing positions
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of mean PAP in three positions
Mean pulmonary arterial pressure pressure (mPAP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure
Measured: During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value
Measurement of PCWP in three positions
Pulmonary capillary wedge pressure (PCWP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure
Measured: During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 May 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Why it stopped: Recruitment challenges and difficulties performing upright hemodynamic measurements using current cath lab setup lead to termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert "Jimmy" Ford, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089164
- Sponsor's protocol ID
- 16-0554
- Status last verified
- Jun 2019
- First submitted
- 20 Mar 2017
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Influence of Postural Changes During Right Heart Catheterization for the Evaluation of Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03089164
- Acronym / sponsor ID
- 16-0554
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment challenges and difficulties performing upright hemodynamic measurements using current cath lab setup lead to termination.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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.
Hemodynamic measurements obtained during pulmonary artery catheterization are essential for the diagnosis and classification of pulmonary hypertension. Traditionally, right heart catheterization (RHC) is done in the supine position. Cardiac output is known to change significantly based on position, due to the effects of gravity on venous return. There has not been a systematic investigation into these postural effects on pulmonary arterial pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to study the differences in measurements obtained during RHC when the patient is supine, seated, and standing.
Detailed description
The investigators also plan a prospective study of patients referred for pulmonary artery catheterization at the UNC cardiac catheterization lab for evaluation of known or suspected pulmonary hypertension. The purpose of this portion of the study is to evaluate the degree to which digital reading of pulmonary artery pressure (PAP) and pulmonary capillary wedge pressure (PCWP) impact the diagnosis and classification of pulmonary hypertension specifically in patients being evaluated for pulmonary hypertension while being tested in the supine, sitting and standing positions.
The investigators will identify 60 patients referred for right heart catheterization to evaluate known or suspected pulmonary hypertension. Patients will have right heart catheterization performed by the clinician that was planning on performing the procedure and a pulmonary hypertension specialist in the Division of Pulmonary and Critical Care Medicine or Division of Cardiology. After informed consent is obtained, the subject will be prepped and draped per protocol in the UNC Cath lab. Their internal jugular vein will be visualized by ultrasound and accessed with a pulmonary artery catheter using standard procedure which also uses fluoroscopy to ensure correct placement of the catheter. Once pressure measurements are obtained from the cardiac chambers and pulmonary arteries, the catheter will be secured into place with tegaderm to allow for mobilization of the patient. The patient will then be asked to sit up on the side of the cath table and the pressure transducer will be re-calibrated to be at the level of the patient's right atrium. Repeat measurements will be obtained of the pulmonary artery and PCWP in this position. After, the patient will be asked to stand up and the pressure transducer once again re-calibrated to estimate the level of the right atrium; new measurements will be obtained in the standing position. Each position will be maintained for 5 minutes before measurements are taken. The supine position measurement will be used for clinical decision making purposes as per usual. The investigators will collect each measurement over at least 10 cardiac cycles and use the mean end-expiratory values to ensure precision.
Once all measurements are obtained, the patient will be asked to return to the supine position. The tegaderm will be released and the catheter removed during sustained expiration maneuver per standard protocol.
No sedation will be administered to the patients.
No further contact will be done with the study subject for the purpose of this research trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be a cohort of patients referred for right heart catheterization for workup of pulmonary arterial hypertension.
Key inclusion criteria (3 listed)
- All patients that are 18 years or older regardless of gender or race,
- are referred for RHC for evaluation of possible Pulmonary Arterial Hypertension (PAH)
- provide informed consent
Key exclusion criteria (1 listed)
- Inability to obtain pulmonary artery pressure or PCWP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right heart catheterizationEach patient will have variables measured supine, sitting and standing positions | Diagnostic test | – |
Primary outcome
Measurement of mean PAP in three positions
Time frame: During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value
Mean pulmonary arterial pressure pressure (mPAP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure
Measurement of PCWP in three positions
Time frame: During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value
Pulmonary capillary wedge pressure (PCWP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure
Results and safety
The study was stopped early (reason given: Recruitment challenges and difficulties performing upright hemodynamic measurements using current cath lab setup lead to termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Hubert "Jimmy" Ford, MD principal investigator
University of North Carolina, Chapel Hill
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 and Right Heart Failure Due to Pulmonary Hypertension, run by University of North Carolina, Chapel Hill 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 1 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: stopped early, as of the sponsor's last update on 27 Jun 2019. 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 was stopped early (reason given: Recruitment challenges and difficulties performing upright hemodynamic measurements using current cath lab setup lead to termination.). Results are not available in the source record.
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?
Measurement of mean PAP in three positions (time frame: During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2019.