Developing a Non-invasive Cardiac Functional Health Status Measurement Device
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 7 - 74 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | January 2015 |
Developing a Non-invasive Cardiac Functional Health Status Measurement Device to be Used in a Critical Population of Adults and Children With Heart Failure.
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 measured at each position. Also, a pulse oximeter will be placed on the
forehead to measure pulse rate and strength. These results will be compared to cardiac
functional classifications defined by New York Heart Association (NYHA) criteria for adults
and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The
primary aim of this initiative is to assess the discriminatory value of a cardiac functional
health classification based upon the degree of dependency of cardiac function on changes in
cardiac preload and afterload circulatory volume.
table and a stress test will be performed in a total of 4 different positions. Their blood
pressure will be measured at each position. Also, a pulse oximeter will be placed on the
forehead to measure pulse rate and strength. These results will be compared to cardiac
functional classifications defined by New York Heart Association (NYHA) criteria for adults
and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The
primary aim of this initiative is to assess the discriminatory value of a cardiac functional
health classification based upon the degree of dependency of cardiac function on changes in
cardiac preload and afterload circulatory volume.
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 Florida. During this visit, Enrolled patients will be placed on a tilt table
and their position changed to a total of 4 different positions. Their blood pressure will be
measured at each position. Also, a pulse oximeter will be placed on the forehead to measure
pulse rate and strength. The study will take approximately 25 minutes. Data collected shall
include a questionnaire for the patient, a list of the patient's co-morbidities, an
echocardiogram or catheter lab data if available, and a list of the patient's current
medications.
any study procedures. The study will consist of a single visit to the Medical Plaza at the
University of Florida. During this visit, Enrolled patients will be placed on a tilt table
and their position changed to a total of 4 different positions. Their blood pressure will be
measured at each position. Also, a pulse oximeter will be placed on the forehead to measure
pulse rate and strength. The study will take approximately 25 minutes. Data collected shall
include a questionnaire for the patient, a list of the patient's co-morbidities, an
echocardiogram or catheter lab data if available, and a list of the patient's current
medications.
Inclusion Criteria:
- 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 Criteria:
- • 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
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