ClinicalTrials.gov
ClinicalTrials.gov Menu

Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02951104
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Santa Barbara Cottage Hospital

Brief Summary:
Comparison of noninvasive cardiac output monitoring device with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Device: Noninvasive cardiac output monitor (NICOM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Actual Study Start Date : November 2016
Estimated Primary Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NICOM Device: Noninvasive cardiac output monitor (NICOM)



Primary Outcome Measures :
  1. Cardiac output measurement correlation at baseline [ Time Frame: 30 minutes ]
    Correlation between cardiac output measurement between NICOM device and Fick and thermodilution methods of cardiac output measurement (standard of care)


Secondary Outcome Measures :
  1. Cardiac output measurement correlation after vasodilator testing [ Time Frame: 30 minutes ]
    Correlation between cardiac output measurement between NICOM device and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 NICOM device 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 NICOM 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951104


Contacts
Contact: Yuri Matusov, MD 805-569-7315 ymatusov@sbch.org

Locations
United States, California
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Yuri Matusov, MD         
Sponsors and Collaborators
Santa Barbara Cottage Hospital

Responsible Party: Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT02951104     History of Changes
Other Study ID Numbers: 16-61
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases