Heart Failure
Conditions
Keywords
cardiac functional health classification, Congenital heart failure, chronic heart failure
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.
Interventions
DEVICECVInsight(TM)
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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Rate | Average pulse rate from baseline to 30 minutes | 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 | Average pulse strength from baseline to 30 minutes | 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. |
Countries
United States
Participant flow
Pre-assignment details
Patients recruited only from two of the study groups (control and post-transplant). Patients from the other groups were not included as study team assessed feasibility with the non-heart failure groups prior to consenting high failure patients. Enrollment was challenging for high risk patients due to stress test severity.
Participants by arm
| Arm | Count |
|---|---|
| Adult Heart Transplant (1a) 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.
CVInsight(TM): 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. | 2 |
| Pediatric Heart Transplant (1b) 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.
CVInsight(TM): 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. | 3 |
| Pediatric Controls 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.
CVInsight(TM): 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Adult Heart Transplant (1a) | Pediatric Heart Transplant (1b) | Pediatric Controls | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| BMI | 27.4 kg/m2 STANDARD_DEVIATION 5 | 28.9 kg/m2 STANDARD_DEVIATION 8.7 | 20.5 kg/m2 STANDARD_DEVIATION 1.7 | 24.4 kg/m2 STANDARD_DEVIATION 6.7 |
| Height | 1.736 meters STANDARD_DEVIATION 0.004 | 1.62 meters STANDARD_DEVIATION 0.03 | 1.64 meters STANDARD_DEVIATION 0.1 | 1.65 meters STANDARD_DEVIATION 0.09 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Weight | 83 kg STANDARD_DEVIATION 15 | 77 kg STANDARD_DEVIATION 25 | 56 kg STANDARD_DEVIATION 11 | 67 kg STANDARD_DEVIATION 21 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Average pulse rate from baseline to 30 minutes
Population: The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.
Primary
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.
Time frame: Average pulse strength from baseline to 30 minutes
Population: The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.