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Developing a Non-invasive Cardiac Functional Health Status Measurement Device

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ClinicalTrials.gov Identifier: NCT01877343
Recruitment Status : Terminated (Challenges associated with study enrollment due to stress test, study terminated)
First Posted : June 13, 2013
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Heart Failure
Intervention Device: CVInsight(TM)
Enrollment 10
Recruitment Details  
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.
Arm/Group Title Adult Heart Transplant (1a) Pediatric Heart Tansplant (1b) Adult Heart Failure Adult Fontan Pediatric Fontan Pediatric Controls Adult Controls
Hide Arm/Group 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.

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.

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 2 3 0 0 0 5 0
Completed 2 3 0 0 0 5 0
Not Completed 0 0 0 0 0 0 0
Arm/Group Title Adult Heart Transplant (1a) Pediatric Heart Transplant (1b) Pediatric Controls Total
Hide Arm/Group 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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 2 3 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants 10 participants
<=18 years
0
   0.0%
2
  66.7%
5
 100.0%
7
  70.0%
Between 18 and 65 years
2
 100.0%
1
  33.3%
0
   0.0%
3
  30.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants 10 participants
Female
2
 100.0%
2
  66.7%
3
  60.0%
7
  70.0%
Male
0
   0.0%
1
  33.3%
2
  40.0%
3
  30.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 2 participants 3 participants 5 participants 10 participants
1.736  (.004) 1.62  (.03) 1.64  (.1) 1.65  (.09)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 2 participants 3 participants 5 participants 10 participants
83  (15) 77  (25) 56  (11) 67  (21)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 2 participants 3 participants 5 participants 10 participants
27.4  (5.0) 28.9  (8.7) 20.5  (1.7) 24.4  (6.7)
1.Primary Outcome
Title Pulse Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CVInsight (TM)
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Pulse Strength
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CVInsight (TM)
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CVInsight (TM)
Hide Arm/Group 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.

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.

All-Cause Mortality
CVInsight (TM)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CVInsight (TM)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CVInsight (TM)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Early termination due concerns for severity of stress test on high risk patients. Only control and post-transplant groups had enrollment. Statistical analysis cannot be performed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Curt DeGroff
Organization: University of Florida
Phone: 352-273-7770
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01877343     History of Changes
Other Study ID Numbers: IRB201300055
First Submitted: April 15, 2013
First Posted: June 13, 2013
Results First Submitted: February 20, 2015
Results First Posted: February 10, 2016
Last Update Posted: February 10, 2016