Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Exercise Testing
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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 |
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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 |
- 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 ]
Estimated Enrollment: | 200 |
Study Start Date: | May 2010 |
Estimated Study Completion Date: | May 2014 |
Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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patients with PH undergoing exercise testing |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
We will enroll 200 consecutive patients referred to the Pulmonary Hypertension Center and scheduled for exercise testing as part of their evaluation of PH.
Inclusion Criteria:
- have Pulmonary Hypertension
- undergoing standard of care exercise testing
- 18 years or older
Exclusion Criteria:
- unable or unwilling to give informed consent
Contact: Jonathan Rich, MD | (773) 702-5589 | jonathan.rich@uchospitals.edu |
Contact: Stuart Rich, MD | (773) 702-5589 | srich@medicine.bsd.uchicago.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Jonathan Rich, MD 773-702-5589 jonathan.rich@uchospitals.edu | |
Contact: Stuart Rich, MD 773-702-5589 srich@medicine.bsd.uchicago.edu | |
Principal Investigator: Stephen Archer, MD | |
Sub-Investigator: Jonathan Rich, MD | |
Sub-Investigator: Stuart Rich, MD |
Principal Investigator: | Stephen Archer, MD | University of Chicago |
No publications provided
Responsible Party: | Stuart Rich, Professor of Medicine, 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: | June 26, 2012 |
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 October 18, 2012