PV Loop and Pulmonary Hypertension

Pulmonary Vascular Resistance Abnormality Clinical Trial

Official title:

Non-Invasive Evaluation of Right Ventricular - Pulmonary Arterial Coupling in Children With Elevated Pulmonary Vascular Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484596
• Other study ID #: PEDS-2020-29351
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Brittany Faanes, MPH, CCRP
• Phone: 612-625-5929
• Email: grego318[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. RV afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. This is response of a ventricle to its afterload is termed ventriculo-arterial (VA) coupling. However, there is a limit to this increase in contractility after which VA uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. The accepted gold standard for measurement of VA coupling is the ratio of the end systolic ventricular elastance (Ees) to the end systolic arterial elastance (Ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. In this study, the aim is to devise a non-invasive scoring system that can identify VA uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac MRI, cardiopulmonary exercise testing and brain natriuretic peptide levels. The hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an RV with VA coupling from that with VA uncoupling.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

Inclusion Criteria:

• Children 1-21 years of age

• Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension

• Structurally normal heart

Exclusion Criteria:

• Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg

• Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension

• Patient will be excluded from performing an MRI if they have:

claustrophobia, metal implants or allergy to contrast

• Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Pulmonary Vascular Resistance Abnormality

Intervention

Procedure:
• Measuring VA Coupling
Subjects will undergo clinically indicated investigations and tests. The research part of the study is measuring the VA coupling using high fidelity catheters. That is expected to increase the duration of the cardiac catheterization for 30 minutes.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	Pediatric Pulmonary Hypertension Program	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Hythem Nawaytou	University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling	Yes/No result: Can echocardiographic measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Three ratios: tricuspid annular plane systolic excursion to the pulmonary artery acceleration time, right ventricular free wall strain to the pulmonary artery acceleration time and, right ventricular fractional area change to the pulmonary artery acceleration time.	within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Primary	Identify cMRI measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling.	Yes/No result: Can cMRI measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Two ratios: right ventricular ejection fraction to right ventricular end systolic volume and right ventricular ejection fraction to pulmonary artery acceleration time (by echocardiography).	within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Primary	Identify 6-minute walk distance cutoff that can identify VA uncoupling	Yes/No: Can 6-minute walk distance identify VA uncoupling (defined as Ees/Es<0.805)	within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Primary	Identify brain natriuretic peptide cutoff value that can identify VA uncoupling	Yes/No: Can brain natriuretic peptide identify VA uncoupling (defined as Ees/Es<0.805)	within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization