Status:
TERMINATED
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
Lead Sponsor:
University of Florida
Conditions:
Heart Failure
Eligibility:
All Genders
7-74 years
Phase:
NA
Brief Summary
This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt table and a stress test will be performed in a total of 4 different positions. Their blood pressure will be mea...
Detailed Description
Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of a single visit to the Medical Plaza at the University of Flo...
Eligibility Criteria
Inclusion
- Heart failure patient eligibility shall consist of the following:
- Group 1a: 5 adult heart transplant patients
- Age ≥ 21 years old and \<74 years old
- Speaks and understands English
- Provides Informed Consent
- Group 1b: 5 pediatric heart transplant patients
- Age ≥ 7 years old and \< 21 years old
- Speaks and understands English
- Provides Informed Consent
- Group 2: 5 adult heart failure patients
- Age ≥ 21 years old and \<74 years old
- Speaks and understands English
- Provides Informed Consent
- Group 3: 5 adult aged Fontan patients
- Age ≥ 21 years old and \<74 years old
- Speaks and understands English
- Provides Informed Consent
- Group 4: 5 pediatric Fontan patients
- Age ≥ 7 years old and \< 21 years old
- Speaks and understands English
- Provides Informed Consent
- Group 5: 5 pediatric patients limited to heart murmurs
- Age ≥ 7 years old and \< 21 years old
- Speaks and understands English
- Provides Informed Consent
- Group 6: 5 normal adult patients
- Age ≥ 21 years old and \<74 years old
- Speaks and understands English
- Provides Informed Consent
Exclusion
- • Unstable patients per judgment of the clinician prior to the start of the treatment
- Patients unable to have blood pressure cuff measured on the upper arm
- Inability to wear monitor on forehead
- Patients will be excluded from the study if they have eaten, consume caffeinated beverages, or taken hypertensive medications within 2 hours of testing
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01877343
Start Date
June 1 2013
End Date
January 1 2015
Last Update
February 10 2016
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610