Clinical trial NCT05484596: PV Loop and Pulmonary Hypertension
Official title: Non-Invasive Evaluation of Right Ventricular - Pulmonary Arterial Coupling in Children With Elevated Pulmonary Vascular Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Vascular Resistance Abnormality
Keywords: pulmonary vascular resistance
pediatric
VA uncoupling
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2022-08-02
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Elevated Pulmonary Arterial Hypertension

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling
timeFrame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
measure: Identify cMRI measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling.
timeFrame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
measure: Identify 6-minute walk distance cutoff that can identify VA uncoupling
timeFrame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
measure: Identify brain natriuretic peptide cutoff value that can identify VA uncoupling
timeFrame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pediatric Pulmonary Hypertension Program
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Gurumurthy Hiremath, MD
role: PRINCIPAL_INVESTIGATOR
References: