Developing a Non-invasive Cardiac Functional Health Status Measurement Device
9 februari 2016 uppdaterad av: University of Florida
Developing a Non-invasive Cardiac Functional Health Status Measurement Device to be Used in a Critical Population of Adults and Children With Heart Failure.
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
10
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 74 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pulse Rate
Tidsram: Average pulse rate from baseline to 30 minutes
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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.
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Average pulse rate from baseline to 30 minutes
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Pulse Strength
Tidsram: Average pulse strength from baseline to 30 minutes
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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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Average pulse strength from baseline to 30 minutes
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2013
Primärt slutförande (Faktisk)
1 januari 2015
Avslutad studie (Faktisk)
1 januari 2015
Studieregistreringsdatum
Först inskickad
15 april 2013
Först inskickad som uppfyllde QC-kriterierna
10 juni 2013
Första postat (Uppskatta)
13 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB201300055
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