Back to resultsDeveloping a Non-invasive Cardiac Functional Health Status Measurement Device
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CVInsight(TM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring cardiac functional health classification, Congenital heart failure, chronic heart failure
Eligibility Criteria
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CVInsight (TM)
Arm Description
Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
Outcomes
Primary Outcome Measures
Pulse Rate
Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.
Pulse Strength
Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01877343
Brief Title
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
Official Title
Developing a Non-invasive Cardiac Functional Health Status Measurement Device to be Used in a Critical Population of Adults and Children With Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Challenges associated with study enrollment due to stress test, study terminated
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
cardiac functional health classification, Congenital heart failure, chronic heart failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVInsight (TM)
Arm Type
Experimental
Arm Description
Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
Intervention Type
Device
Intervention Name(s)
CVInsight(TM)
Intervention Description
Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
Primary Outcome Measure Information:
Title
Pulse Rate
Description
Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.
Time Frame
Average pulse rate from baseline to 30 minutes
Title
Pulse Strength
Description
Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.
Time Frame
Average pulse strength from baseline to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curt DeGroff, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
We'll reach out to this number within 24 hrs