Developing a Non-invasive Cardiac Functional Health Status Measurement Device

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01877343

Run by

University of Florida

People needed

10

Starts

2013-06-01

Expected to finish

2015-01-01

Last updated by the study team

2016-02-10

Who can join

Age: 7 and older, up to 74. Sex: any. Healthy volunteers: accepted.

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
• 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

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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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