PV Loop and Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Vascular Resistance Abnormality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group

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.

Measuring VA Coupling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No