Developing a Non-invasive Cardiac Functional Health Status Measurement Device

NCT01877343 | Terminated Results

• 1 other identifier: IRB201300055
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

cardiac functional health classification; Congenital heart failure; chronic heart failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

CVInsight (TM)

EXPERIMENTAL

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.

Device: CVInsight(TM)

Interventions

CVInsight(TM) DEVICE

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.

CVInsight (TM)

Eligibility Criteria

• Age: 7 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Curt DeGroff
• Organization: University of Florida

degroffc@peds.ufl.edu

352-273-7770

Study Officials

• Curt DeGroff, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 10, 2016
• Results First Posted: February 10, 2016

Record last verified: 2016-02

Locations

US (1)