Pulmonary HypertensionNCT05343091
Prognostic Value of the Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Cardiac Ultrasound
- What is being tested?
- cardiac ultrasound
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2021to 31 Jan 2023
- How long will I take part?
- 9 Months
- 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 with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.
Who may be able to join
- Patients with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.
- Presence of a baseline transthoracic echocardiogram as well as a follow-up echocardiogram.
- Presence of 6m baseline walk as well as follow-up.
Who cannot join
- All patients with left heart disease associated with PH
- All patients with pulmonary disease associated with PH
- All patients with congenital heart disease who had poor surgical repair.
- Patients who meet the contraindication by the American chest guidelines to perform the 6m walk test.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico City, 14080
Jose Luis Hernández Oropeza, Ph, (55) 5487 0900 ext. 2209, elinternista@hotmail.com
Pamela Mercado Velázquez, MD, (55) 5487 0900 ext. 2152, pamela.mercado@incmnsz.mx
About this study
Official title: Prognostic Value of the Evaluation of Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.
Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.
There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.
There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.
Transthoracic Echocardiography (TTE) currently plays an important role in the diagnostic algorithm of PAH as it is minimally invasive and readily available. Moreover, many echocardiographic parameters are closely related to pulmonary hemodynamics. Some TTE parameters are associated with mortality and surviving in these patients, such as: shortening fraction, presence of pericardial effusion, eccentricity index, systolic displacement of the tricuspid annular plane (TAPSE), size of the right atrium and right ventricular free wall strain.
Ultrasound (US) is the only method which enables realtime bedside imaging of the heart. Focused cardiac US provides worthy diagnostic information useful for the the clinical management of critical care patients. The use of cardiac ultrasound in the last decade has gradually increased among non cardiologists. Pocket ultrasounds are part of the third generation of ultrasounds described in the literature. These have the characteristic of being light devices weighing less than 1kg and that can be carried in the pocket of the medical uniform. This leads many researchers to believe that in the not too distant future its use will be part of the physical examination routine, as the stethoscope is now.
There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.
STATEMENT OF THE PROBLEM Does the measurement of tricuspid annular plane systolic displacement (TAPSE) by portable cardiac ultrasound have prognostic utility in the follow-up of patients with Pulmonary Hypertension?
JUSTIFICATION There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. However, the high costs of an apparatus to perform the standard echocardiogram study and the prolonged appointments to perform the study delay the diagnosis of treatment of progression of cardiovascular disease. Therefore, it is important to document the usefulness of using an accessible medical tool during the cardiopulmonology consultation for the follow-up of patients with pulmonary hypertension.
HYPOTHESIS Patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE.
- Being tested
- cardiac ultrasound
- Keywords
- Pulmonary hypertension, cardiac ultrasound, tricuspid annular plane systolic excursion, pulmonary arterial hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac ultrasoundDevice
Cardiac ultrasound with Pocket ultrasound by expert and non expert physician
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension patients | patients with diagnosis of Pulmonary Hypertension from group 1 and 4 by right heart catheterization Receives: Device: cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity events with TAPSE
Estimate the risk of morbidity events, between patients with PH who have a low TAPSE and those with a normal TAPSE.
Measured: 9 months
Secondary outcomes (2)
right heart dysfunction
estimate the prevalence of right heart dysfunction in outpatients with pulmonary hypertension in the INCMNSZ
Measured: 9 months
other ultrasound parameters
Show that the presence of pericardial effusion, a right atrial area >34 ml and the presence of septal deviation measured by portable cardiac ultrasound are associated with higher morbidity and mortality events.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
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
- 62 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Pamela Mercado Velázquez, Consuelo Orihuela Sandoval, Tatiana Sofia Rodríguez Reyna, Ivette Buendía Roldán
- Responsible party
- Principal investigator, Jose Luis Hernandez Oropeza, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343091
- Sponsor's protocol ID
- 3492
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 27 May 2022
- 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 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Evaluation of Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT05343091
- Acronym / sponsor ID
- 3492
- Keywords
- Pulmonary hypertension, cardiac ultrasound, tricuspid annular plane systolic excursion, pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Pamela Mercado Velázquez, Consuelo Orihuela Sandoval, Tatiana Sofia Rodríguez Reyna, Ivette Buendía Roldán
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 25 Apr 2022 (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.
Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.
There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.
There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound.
Detailed description
Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.
Transthoracic Echocardiography (TTE) currently plays an important role in the diagnostic algorithm of PAH as it is minimally invasive and readily available. Moreover, many echocardiographic parameters are closely related to pulmonary hemodynamics. Some TTE parameters are associated with mortality and surviving in these patients, such as: shortening fraction, presence of pericardial effusion, eccentricity index, systolic displacement of the tricuspid annular plane (TAPSE), size of the right atrium and right ventricular free wall strain.
Ultrasound (US) is the only method which enables realtime bedside imaging of the heart. Focused cardiac US provides worthy diagnostic information useful for the the clinical management of critical care patients. The use of cardiac ultrasound in the last decade has gradually increased among non cardiologists. Pocket ultrasounds are part of the third generation of ultrasounds described in the literature. These have the characteristic of being light devices weighing less than 1kg and that can be carried in the pocket of the medical uniform. This leads many researchers to believe that in the not too distant future its use will be part of the physical examination routine, as the stethoscope is now.
There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.
STATEMENT OF THE PROBLEM Does the measurement of tricuspid annular plane systolic displacement (TAPSE) by portable cardiac ultrasound have prognostic utility in the follow-up of patients with Pulmonary Hypertension?
JUSTIFICATION There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. However, the high costs of an apparatus to perform the standard echocardiogram study and the prolonged appointments to perform the study delay the diagnosis of treatment of progression of cardiovascular disease. Therefore, it is important to document the usefulness of using an accessible medical tool during the cardiopulmonology consultation for the follow-up of patients with pulmonary hypertension.
HYPOTHESIS Patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension patients | – | Device: cardiac ultrasoundpatients with diagnosis of Pulmonary Hypertension from group 1 and 4 by right heart catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.
Key inclusion criteria (3 listed)
- Patients with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.
- Presence of a baseline transthoracic echocardiogram as well as a follow-up echocardiogram.
- Presence of 6m baseline walk as well as follow-up.
Key exclusion criteria (4 listed)
- All patients with left heart disease associated with PH
- All patients with pulmonary disease associated with PH
- All patients with congenital heart disease who had poor surgical repair.
- Patients who meet the contraindication by the American chest guidelines to perform the 6m walk test.
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 |
|---|---|---|
| cardiac ultrasoundCardiac ultrasound with Pocket ultrasound by expert and non expert physician | Device | Pulmonary Hypertension patients |
Primary outcome
morbidity events with TAPSE
Time frame: 9 months
Estimate the risk of morbidity events, between patients with PH who have a low TAPSE and those with a normal TAPSE.
2 secondary outcomes
right heart dysfunction
Time frame: 9 months
other ultrasound parameters
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- 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.
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 Pulmonary Arterial Hypertension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 4 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: status not confirmed, as of the sponsor's last update on 27 May 2022. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Hernández Oropeza, Ph ((55) 5487 0900 ext. 2209, elinternista@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity events with TAPSE (time frame: 9 months). 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 May 2022.