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Completed

NCT Number: NCT02951104

Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Completed

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Diagnosis of Group 1 or Group 4 PAH based on PAPm > 25 mmHg, PAWP <15 mmHg, PVR >3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
  • Willingness and ability to comply with study procedures.
  • No known hypersensitivity to the components of USCOM electrodes

Exclusion criteria

  • Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
  • Evidence of postcapillary pulmonary hypertension on right heart catheterization

Treatment and study plan

Ultrasonic Cardiac Output Monitor (USCOM) system

Device

Primary outcomes

  1. Cardiac output measurement correlation at baseline

    Time frame: 30 minutes

    Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)

Secondary outcomes

  1. Cardiac output measurement correlation after vasodilator testing

    Time frame: 30 minutes

    Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing

Sponsors and collaborators

Lead sponsor

Santa Barbara Cottage Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Nov 1, 2016
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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