Trial Outcomes & Findings for Developing a Non-invasive Cardiac Functional Health Status Measurement Device (NCT NCT01877343)

Last Updated: 2016-02-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Average pulse rate from baseline to 30 minutes

Results posted on

2016-02-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Pediatric Heart Tansplant (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.	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.
Overall Study STARTED	2	3	5
Overall Study COMPLETED	2	3	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing a Non-invasive Cardiac Functional Health Status Measurement Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Heart Transplant (1a) n=2 Participants 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.	Pediatric Heart Transplant (1b) n=3 Participants 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.	Pediatric Controls n=5 Participants 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 n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Height	1.736 meters STANDARD_DEVIATION .004 • n=5 Participants	1.62 meters STANDARD_DEVIATION .03 • n=7 Participants	1.64 meters STANDARD_DEVIATION .1 • n=5 Participants	1.65 meters STANDARD_DEVIATION .09 • n=4 Participants
Weight	83 kg STANDARD_DEVIATION 15 • n=5 Participants	77 kg STANDARD_DEVIATION 25 • n=7 Participants	56 kg STANDARD_DEVIATION 11 • n=5 Participants	67 kg STANDARD_DEVIATION 21 • n=4 Participants
BMI	27.4 kg/m2 STANDARD_DEVIATION 5.0 • n=5 Participants	28.9 kg/m2 STANDARD_DEVIATION 8.7 • n=7 Participants	20.5 kg/m2 STANDARD_DEVIATION 1.7 • n=5 Participants	24.4 kg/m2 STANDARD_DEVIATION 6.7 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

CVInsight (TM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Curt DeGroff

University of Florida

Phone: 352-273-7770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place