Heart Failure, DiastolicPhase 1/2RF-SPEEDNCT01182805
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
A Phase 1/2 study testing Echocardiography system Ultra DCI Model 5000, Echocardiography machine GE Vivid E9 and Diastolic function assessment in people with Heart Failure, Diastolic, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Echocardiography system Ultra DCI Model 5000, Echocardiography machine GE Vivid E9 and Diastolic function assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.
Who cannot join
- Suspected acute ST elevation myocardial infarction.
- Acute coronary syndrome with active ongoing chest pain
- Known or suspected acute aortic dissection
- Known or suspected cardiac tamponade
- Known history of unoperated constrictive pericarditis
- Known or suspected severe aortic stenosis or severe mitral regurgitation
Show all 9Show fewer
- Heart rhythm other than sinus rhythm on pre-cath EKG
- Age < 18 years old
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109-5853
About this study
The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.
- Conditions
- Heart Failure, Diastolic
- Being tested
- Echocardiography system Ultra DCI Model 5000, Echocardiography machine GE Vivid E9, Diastolic function assessment
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography system Ultra DCI Model 5000Device
Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.
Echocardiography machine GE Vivid E9Device
Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.
Diastolic function assessmentDevice
Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study. | Other | Not described Receives: Device: Echocardiography system Ultra DCI Model 5000; Device: Echocardiography machine GE Vivid E9; Device: Diastolic function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic Circumferential Strain Rate During Isovolumic Relaxation
Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.
Measured: Assessed from echo obtained at time of enrollment
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler
E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Measured: Assessed from echo obtained at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Pixel Velocity, Inc. / Epsilon Imaging, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Theodore J. Kolias, University of Michigan
- Investigators
- Theodore J Kolias, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182805
- Sponsor's protocol ID
- RF-SPEED
- Other IDs
- 5R44HL071379
- Acronym
- RF-SPEED
- Status last verified
- Oct 2023
- First submitted
- 12 Aug 2010
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
- ClinicalTrials.gov ID
- NCT01182805
- Acronym / sponsor ID
- RF-SPEED / RF-SPEED
- Conditions
- Heart Failure, Diastolic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Pixel Velocity, Inc. / Epsilon Imaging, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 3 Aug 2012
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 this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study. | Other | Device: Echocardiography system Ultra DCI Model 5000, Device: Echocardiography machine GE Vivid E9, Device: Diastolic function assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.
Key exclusion criteria (9 listed)
- Suspected acute ST elevation myocardial infarction.
- Acute coronary syndrome with active ongoing chest pain
- Known or suspected acute aortic dissection
- Known or suspected cardiac tamponade
- Known history of unoperated constrictive pericarditis
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 |
|---|---|---|
| Echocardiography system Ultra DCI Model 5000Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function. | Device | Single arm study. |
| Echocardiography machine GE Vivid E9Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function. | Device | Single arm study. |
| Diastolic function assessmentEach subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study. | Device | Single arm study. |
Primary outcome
Diastolic Circumferential Strain Rate During Isovolumic Relaxation
Time frame: Assessed from echo obtained at time of enrollment
Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler
Time frame: Assessed from echo obtained at time of enrollment
E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heart Failure, Diastolic
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease
Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
RecruitingObservational study
Common Femoral Vein-to-Artery Diameter Ratio for Detection of Elevated LVEDP
Acute Coronary Syndrome, Chronic Coronary Syndrome
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.
Theodore J Kolias, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Echocardiography system Ultra DCI Model 5000, Echocardiography machine GE Vivid E9 and Diastolic function assessment in people with Heart Failure, Diastolic, run by University of Michigan at 1 site 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 9 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diastolic Circumferential Strain Rate During Isovolumic Relaxation (time frame: Assessed from echo obtained at time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2023.