Developing a Non-invasive Cardiac Functional Health Status Measurement Device (NCT01877343) | Clinical Trial Compass
TerminatedNot Applicable
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
Stopped: Challenges associated with study enrollment due to stress test, study terminated
United States10 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
7 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulse Rate
Timeframe: Average pulse rate from baseline to 30 minutes
2
Pulse Strength
Timeframe: Average pulse strength from baseline to 30 minutes