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

NCT ID: NCT05343091

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-01-31

Brief 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. 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.

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension; Cardiac Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pulmonary Hypertension patients

patients with diagnosis of Pulmonary Hypertension from group 1 and 4 by right heart catheterization

cardiac ultrasound

Intervention Type: DEVICE

Cardiac ultrasound with Pocket ultrasound by expert and non expert physician

Interventions

cardiac ultrasound

Cardiac ultrasound with Pocket ultrasound by expert and non expert physician

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamela Mercado Velázquez

UNKNOWN

Sponsor Role: collaborator

Consuelo Orihuela Sandoval

UNKNOWN

Sponsor Role: collaborator

Tatiana Sofia Rodríguez Reyna

UNKNOWN

Sponsor Role: collaborator

Ivette Buendía Roldán

UNKNOWN

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Jose Luis Hernandez Oropeza

PhD, Head of Cardiopneumology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Jose Luis Hernández Oropeza, Ph

Role: CONTACT

elinternista@hotmail.com

(55) 5487 0900 ext. 2209

Pamela Mercado Velázquez, MD

Role: CONTACT

pamela.mercadov@incmnsz.mx

(55) 5487 0900 ext. 2152

Facility Contacts

Jose Luis Hernández Oropeza, Ph

Role: primary

elinternista@hotmail.com

(55) 5487 0900 ext. 2209

Pamela Mercado Velázquez, MD

Role: backup

pamela.mercado@incmnsz.mx

(55) 5487 0900 ext. 2152

Other Identifiers

3492

Identifier Type: -

Identifier Source: org_study_id