PV Loop and Pulmonary Hypertension

Status unconfirmed

Conditions studied: Pulmonary Vascular Resistance Abnormality

In brief

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.

Key facts

Study ID

NCT05484596

Run by

Hythem Nawaytou

People needed

65

Starts

2020-04-27

Expected to finish

2025-04-30

Last updated by the study team

2023-09-26

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children 1-21 years of age
• Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension
• Structurally normal heart

You may not qualify if…

• 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.

Where it is running

• Pediatric Pulmonary Hypertension Program — San Francisco, California, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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