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Developing a Non-invasive Cardiac Functional Health Status Measurement Device

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ClinicalTrials.gov Identifier: NCT01877343
Recruitment Status : Terminated (Challenges associated with study enrollment due to stress test, study terminated)
First Posted : June 13, 2013
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CVInsight(TM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : June 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Pulse Rate [ Time Frame: Average pulse rate from baseline to 30 minutes ]
    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.

  2. Pulse Strength [ Time Frame: Average pulse strength from baseline to 30 minutes ]
    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.



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Ages Eligible for Study:   7 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877343


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Curt DeGroff, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01877343     History of Changes
Other Study ID Numbers: IRB201300055
First Posted: June 13, 2013    Key Record Dates
Results First Posted: February 10, 2016
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by University of Florida:
cardiac functional health classification
Congenital heart failure
chronic heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases