PV Loop and Pulmonary Hypertension

NCT05484596 | Unknown FDA Device

• 1 other identifier: PEDS-2020-29351
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Vascular Resistance Abnormality

Keywords

pulmonary vascular resistance; pediatric; VA uncoupling

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Procedure: Measuring VA Coupling

Interventions

Measuring VA Coupling 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.

Observational Group

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with Elevated Pulmonary Arterial Hypertension

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.

Sponsors & Collaborators

• Hythem Nawaytou: lead
• University of Minnesota: collaborator

Study Sites (2)

Pediatric Pulmonary Hypertension Program

San Francisco, California, 94143, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

• Gurumurthy Hiremath, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Faanes, MPH, CCRP

CONTACT

612-625-5929; grego318@umn.edu

Jasmine Becerra, BS

CONTACT

415-476-2649; jasmine.becerra@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: August 2, 2022
• Study Start: April 27, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (2)