Developing a Non-invasive Cardiac Functional Health Status Measurement Device

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01877343
• Other study ID #: IRB201300055
• Status: Terminated
• Phase: N/A
• First received: April 15, 2013
• Last updated: February 9, 2016
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 74 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Average pulse rate from baseline to 30 minutes	No
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.	Average pulse strength from baseline to 30 minutes	No