Developing a Non-invasive Cardiac Functional Health Status Measurement Device

NCT ID: NCT01877343

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.

Group Type: EXPERIMENTAL

CVInsight(TM)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curt DeGroff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201300055

Identifier Type: -

Identifier Source: org_study_id