CardiomyopathiesNCT03534726
Edema and Fibrosis CMR Imaging in Cardiomyopathy
An observational study of Cardiomyopathies, run by University of Pennsylvania at 1 site in United States.
Trial summary
7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- 7 T CMR
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The eligible population are cardiomyopathy patients and normal volunteers.
Who may be able to join
- Subjects between the ages of 20-70 years old
Who cannot join
- Advanced renal disease (estimated GFR rate < 30 mL/min) or hypersensitivity to gadolinium contrast agent.
- Presence of cardiac pacemaker or implanted cardioverter defibrillator
- Pregnancy
- Inability to provide informed consent
- Other contraindications to MRI (such as claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. The purpose of this study is to assess the feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.
- Conditions
- Cardiomyopathies
- Being tested
- 7 T CMR
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 T CMRDevice
7 tesla MRI device
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with cardiomyopathy Receives: Device: 7 T CMR | |
| Normal subjects | No prior history of heart disease. Receives: Device: 7 T CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
ejection fraction
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534726
- Sponsor's protocol ID
- 827516
- Status last verified
- Feb 2026
- First submitted
- 11 May 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03534726
- Acronym / sponsor ID
- 827516
- Conditions
- Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2018 (actual)
- 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.
7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. The purpose of this study is to assess the feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: 7 T CMRPatients with cardiomyopathy |
| Normal subjects | – | Device: 7 T CMRNo prior history of heart disease. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible population are cardiomyopathy patients and normal volunteers.
Key inclusion criteria (1 listed)
- Subjects between the ages of 20-70 years old
Key exclusion criteria (5 listed)
- Advanced renal disease (estimated GFR rate < 30 mL/min) or hypersensitivity to gadolinium contrast agent.
- Presence of cardiac pacemaker or implanted cardioverter defibrillator
- Pregnancy
- Inability to provide informed consent
- Other contraindications to MRI (such as 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 |
|---|---|---|
| 7 T CMR7 tesla MRI device | Device | Normal subjects, Patients |
Primary outcome
ejection fraction
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiomyopathies
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by University of Pennsylvania 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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
ejection fraction (time frame: 5 years). 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 6 Feb 2026.