Recruiting

Observational Study

Sponsor:

Hythem Nawaytou

Code:

NCT05484596

Conditions

Pulmonary Vascular Resistance Abnormality

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

Measuring VA Coupling

Study Details

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

Study ID

NCT05484596

Start date

Apr 27, 2020

Status verified date

Sep, 2023

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

65 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling [ Time Frame: 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. [ Time Frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization ]
  • Identify 6-minute walk distance cutoff that can identify VA uncoupling [ Time Frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization ]
  • Identify brain natriuretic peptide cutoff value that can identify VA uncoupling [ Time Frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization ]

Central Contacts and Locations

Central contacts

Brittany Faanes, MPH, CCRP

612-625-5929grego318@umn.edu

Locations

Pediatric Pulmonary Hypertension Program

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Hythem Nawaytou, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Brittany Faanes, MPH, CCRP

612-625-5929grego318@umn.edu

Principal Investigator:

Gurumurthy Hiremath, MD

More Information

Sponsor

Hythem Nawaytou

Last update posted

Sep 26, 2023

Last verified

Sep, 2023

Keywords

  • pulmonary vascular resistance
  • pediatric
  • VA uncoupling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hythem Nawaytou on 2023-09-26.