Heart FailureNCT02240979
Establishing a Non-invasive Method to Measure Your Heart's Performance
An observational study of Heart Failure, run by Marie Csete MD, PhD at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate a new way to examine cardiac function, using software developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where the carotid pulse can be felt. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- cardiac MRI
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with normal and abnormal cardiac function will be studied.
Who may be able to join
- Adult age 18-90, outpatients
Who cannot join
- Inability to lie flat for 30 minutes with periodic breath holding
- Metal implants or other standard contraindications to MRI
- Acute cardiac decompensation (active chest pain, shortness of breath)
- Hypotension (SBP<90 mm Hg)
- Claustrophobia
- Patient too large to fit in closed MRI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avicena LLC
Pasadena, California, 91105
Huntington Medical Research Institutes MR Imaging Center
Pasadena, California, 91105
About this study
Official title: Establishing a Non-invasive Method to Measure Heart Performance
The purpose of the study is to evaluate a new way to examine cardiac function, using software developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where the carotid pulse can be felt. In this study the information collected from the iPhone app is compared to cardiac function data obtained from the current gold standard for measuring cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from cardiologists will also generally have echocardiography information available for comparison with the iPhone app. For the study, subjects will have completely non-invasive studies done in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist) arteries), tonometry (another non-invasive method using a modified stethoscope), standard pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study will be done about 6 months after the first. The complete study session takes about 1.5 hours.
Read the detailed description
Investigators at Caltech have developed an iPhone-based application that allows them to capture an arterial waveform using the iPhone camera held over the skin. Then based on the captured waveform and previous laboratory experiments and models, the investigators are able to calculate ejection fraction, the percentage of blood that goes out of the heart into the circulation with each beat. Previous studies suggested that the iPhone app measurements of ejection fraction were similar to those obtained with traditional cardiac echocardiography. In the current study the iPhone app measures are being compared to ejection fraction obtained using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta that the investigators call "intrinsic frequencies". Using healthy subjects they have established the normal pattern/range of intrinsic frequencies, and in this study, a more diverse population of subjects (some with heart disease) will be studied, to determine how intrinsic frequency measures compare to traditional clinical measures of cardiac function.
- Conditions
- Heart Failure
- Being tested
- cardiac MRI
- Keywords
- arterial waveform, cardiac magnetic resonance imaging, echocardiography, intrinsic frequency measures of cardiac function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac MRIDevice
cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| Adults able to undergo cardiac MRI exam | Adults able to undergo cardiac MRI Receives: Device: cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance measures of cardiac function
Standard end-points of cardiac function such as chamber size and relaxation.
Measured: Within 1 month of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie Csete MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, California Institute of Technology
- Responsible party
- Sponsor-investigator, Marie Csete MD, PhD, Huntington Medical Research Institutes
- Investigators
- Marie Csete, MD, PhD, Study chair, Ventric Health, LLCNiema Pahlevan, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240979
- Sponsor's protocol ID
- HMRI-10Pico-1
- Other IDs
- CIT2014
- Status last verified
- May 2019
- First submitted
- 12 Sep 2014
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript was submitted in February 2016 reporting results of the study. In editorial process.
Publications
Pahlevan NM, Tavallali P, Rinderknecht DG, Petrasek D, Matthews RV, Hou TY, Gharib M. Intrinsic frequency for a systems approach to haemodynamic waveform analysis with clinical applications. J R Soc Interface. 2014 Sep 6;11(98):20140617. doi: 10.1098/rsif.2014.0617.
PubMed 25008087Niroumandi S, Rinderknecht D, Bilgi C, Cole S, Ogbonnaya SA, Wolfson AM, Vaidya AS, King KS, Pahlevan NM. Smartphone Measurement of Aortic Arch Pulse-Wave Velocity and Total Arterial Compliance: Accessible Local and Global Arterial Stiffness Assessment. J Am Heart Assoc. 2026 Feb 17;15(4):e043563. doi: 10.1161/JAHA.125.043563. Epub 2026 Feb 11.
PubMed 41669977
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Non-invasive Method to Measure Heart Performance
- ClinicalTrials.gov ID
- NCT02240979
- Acronym / sponsor ID
- HMRI-10Pico-1
- Conditions
- Heart Failure
- Keywords
- arterial waveform, cardiac magnetic resonance imaging, echocardiography, intrinsic frequency measures of cardiac function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Marie Csete MD, PhDUniversity, hospital or other
- Collaborators
- University of Southern California, California Institute of Technology
- Study start
- Aug 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate a new way to examine cardiac function, using software developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where the carotid pulse can be felt. In this study the information collected from the iPhone app is compared to cardiac function data obtained from the current gold standard for measuring cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from cardiologists will also generally have echocardiography information available for comparison with the iPhone app. For the study, subjects will have completely non-invasive studies done in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist) arteries), tonometry (another non-invasive method using a modified stethoscope), standard pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study will be done about 6 months after the first. The complete study session takes about 1.5 hours.
Detailed description
Investigators at Caltech have developed an iPhone-based application that allows them to capture an arterial waveform using the iPhone camera held over the skin. Then based on the captured waveform and previous laboratory experiments and models, the investigators are able to calculate ejection fraction, the percentage of blood that goes out of the heart into the circulation with each beat. Previous studies suggested that the iPhone app measurements of ejection fraction were similar to those obtained with traditional cardiac echocardiography. In the current study the iPhone app measures are being compared to ejection fraction obtained using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta that the investigators call "intrinsic frequencies". Using healthy subjects they have established the normal pattern/range of intrinsic frequencies, and in this study, a more diverse population of subjects (some with heart disease) will be studied, to determine how intrinsic frequency measures compare to traditional clinical measures of cardiac function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults able to undergo cardiac MRI exam | – | Device: cardiac MRIAdults able to undergo cardiac MRI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with normal and abnormal cardiac function will be studied.
Key inclusion criteria (1 listed)
- Adult age 18-90, outpatients
Key exclusion criteria (6 listed)
- Inability to lie flat for 30 minutes with periodic breath holding
- Metal implants or other standard contraindications to MRI
- Acute cardiac decompensation (active chest pain, shortness of breath)
- Hypotension (SBP<90 mm Hg)
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac MRIcardiac MRI | Device | Adults able to undergo cardiac MRI exam |
Primary outcome
Magnetic resonance measures of cardiac function
Time frame: Within 1 month of study
Standard end-points of cardiac function such as chamber size and relaxation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Background: PubMed 25008087Pahlevan NM, Tavallali P, Rinderknecht DG, Petrasek D, Matthews RV, Hou TY, Gharib M. Intrinsic frequency for a systems approach to haemodynamic waveform analysis with clinical applications. J R Soc Interface. 2014 Sep 6;11(98):20140617. doi: 10.1098/rsif.2014.0617.
- Derived from this study: PubMed 41669977Niroumandi S, Rinderknecht D, Bilgi C, Cole S, Ogbonnaya SA, Wolfson AM, Vaidya AS, King KS, Pahlevan NM. Smartphone Measurement of Aortic Arch Pulse-Wave Velocity and Total Arterial Compliance: Accessible Local and Global Arterial Stiffness Assessment. J Am Heart Assoc. 2026 Feb 17;15(4):e043563. doi: 10.1161/JAHA.125.043563. Epub 2026 Feb 11.
- Individual participant dataSharing planned: Yes. A manuscript was submitted in February 2016 reporting results of the study. In editorial process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Csete, MD, PhD study chair
Ventric Health, LLC
Niema Pahlevan, PhD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Marie Csete MD, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance measures of cardiac function (time frame: Within 1 month of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.