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Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing

Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01275690
Enrollment
0
Registered
2011-01-12
Start date
2010-05-31
Completion date
2014-05-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

cardiac, pulmonary hypertension, To determine the accuracy of a noninvasive method of measuring cardiac output as compared to the standard invasive approach in patients with PH

Brief summary

Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors have referred them for a right heart catheterization (RHC). Heart catheterization involves inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to the heart (sometimes this procedure can be done through a vein in the groin instead). Once the catheter is in place, small instruments can be inserted into the catheter to measure the pressures in different areas of the heart. These measurements can help the doctor diagnose possible problems with the heart functioning. The purpose of this study is to evaluate the measurements provided by a device, called Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. While the device has been approved for use in any patient, it remains possible that patients with PH will have differences in the way the device calculates measurements. In this study, the investigators will compare the in-the-body (right heart catheterization) measurements to the non-invasive, outside-body measurements provided by the NICOM device to evaluate any differences. The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the right heart catheterization procedure that is scheduled as part of the patients' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.

Interventions

None listed

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years old and up * have Pulmonary Hypertension (PH) * Scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH

Exclusion criteria

* unable or unwilling to give informed consent

Design outcomes

Primary

MeasureTime frame
To determine the accuracy of a noninvasive method of measuring cardiac output as compared to the standard invasive approach using thermodilution in patients with pulmonary hypertension2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026