Prognostic Value of the Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension; Cardiac Ultrasound
• Intervention / Treatment: Device: cardiac 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 Type: Observational
• Enrollment (Anticipated): 62

Contacts and Locations

• Study Contact: Name: Jose Luis Hernández Oropeza, Ph; Phone Number: 2209 (55) 5487 0900; Email: elinternista@hotmail.com
• Study Contact Backup: Name: Pamela Mercado Velázquez, MD; Phone Number: 2152 (55) 5487 0900; Email: pamela.mercadov@incmnsz.mx

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Contact: Jose Luis Hernández Oropeza, Ph; Phone Number: 2209 (55) 5487 0900; Email: elinternista@hotmail.com
    • Contact: Pamela Mercado Velázquez, MD; Phone Number: 2152 (55) 5487 0900; Email: pamela.mercado@incmnsz.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Hypertension patients; patients with diagnosis of Pulmonary Hypertension from group 1 and 4 by right heart catheterization	Device: cardiac ultrasound; Cardiac ultrasound with Pocket ultrasound by expert and non expert physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
right heart dysfunction	estimate the prevalence of right heart dysfunction in outpatients with pulmonary hypertension in the INCMNSZ	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.	9 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Pamela Mercado Velázquez; Consuelo Orihuela Sandoval; Tatiana Sofia Rodríguez Reyna; Ivette Buendía Roldán

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary hypertension; pulmonary arterial hypertension; cardiac ultrasound; tricuspid annular plane systolic excursion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 3492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No