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Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Exercise Testing

This study has been withdrawn prior to enrollment.
(The PI left this institution, and the study was closed.)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01275703
First received: January 10, 2011
Last updated: December 21, 2015
Last verified: December 2015
  Purpose

Subjects in this study have been diagnosed with pulmonary hypertension and their doctors have referred them for an exercise test as part of their normal, routine care. The exercise test will either be a treadmill test or a 6 minute walk test. During a treadmill test, a patient typically walks on a treadmill while their heart is monitored using an electrocardiogram, which records the electrical activity of the heart through 10 small electrode patches attached to the skin of the chest, arms and legs. Additionally, heart rate and blood pressure are monitored throughout the test. A 6-Minute Walk test requires patients to walk for up to 6 minutes to determine how far they can go in order to measure the heart function related to exercise.

The purpose of this study is to measure internal heart pressures using a device called Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart pressures are measured during invasive (meaning that doctors have to go inside the body using a needle or surgery) heart procedures. The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. In this study, the investigators will evaluate the non-invasive measurements provided by the NICOM device during the exercise test and see how it relates to information from some of subjects' past heart procedures. This research is being done to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy.

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 exercise test that is scheduled as part of the subjects' 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.


Condition
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Exercise Testing

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To determine the utility of a noninvasive method of measuring cardiac output during exercise testing in patients with pulmonary hypertension [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2010
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with PH undergoing exercise testing

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will enroll 200 consecutive patients referred to the Pulmonary Hypertension Center and scheduled for exercise testing as part of their evaluation of PH.
Criteria

Inclusion Criteria:

  • have Pulmonary Hypertension
  • undergoing standard of care exercise testing
  • 18 years or older

Exclusion Criteria:

  • unable or unwilling to give informed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275703

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stephen Archer, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01275703     History of Changes
Other Study ID Numbers: 10-180-B 
Study First Received: January 10, 2011
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
To determine the utility of a noninvasive method of measuring cardiac output during exercise testing in patients with PH

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

ClinicalTrials.gov processed this record on September 29, 2016