Heart Failure With Preserved Ejection FractionNCT03340233
Understanding the Mechanisms of Diastolic Dysfunction
A study testing MRI (cardiac) off-label use gadolinium contrast (IND exempt) and MRI (cardiac) in people with Heart Failure With Preserved Ejection Fraction and Healthy, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Heart failure is a clinical syndrome marked by breathlessness, even at low levels of exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people in the United States. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Healthy
- What is being tested?
- MRI (cardiac) off-label use gadolinium contrast (IND exempt) and MRI (cardiac)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to Aug 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- 1. Healthy adults
- Patients with Heart Failure with Preserved Ejection Fraction
- Patient scheduled for catheterization at UCLA Medical Center
- Ejection fraction >/= 50%
- Signs and symptoms of heart failure
- Excluded other potential non-cardiac etiologies of heart failure
Who cannot join
- Healthy volunteers
- Known medical condition that impacts heart health
- Contraindications to MRI (e.g., pacemaker/ICD, or claustrophobia)
- Patients with Heart Failure with Preserved Ejection Fraction
- Contraindications to MRI (e.g., pacemaker/ICD, or claustrophobia)
- Prior MI or history of PCI/CABG
Show all 10Show fewer
- Worse than mild valvular disease
- Any indication for ICD implantation
- Contraindication to MRI contrast agents or eGRF <30 ml/min/1.73m2 or MRI exams (e.g., pacemaker/ICD or claustrophobia).
- Atrial fibrillation or unstable cardiac rhythm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90024
About this study
Official title: A New Framework for Understanding the Mechanism of Diastolic Dysfunction
Heart failure is a clinical syndrome marked by breathlessness, even at low levels of exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people in the United States. Heart failure with preserved ejection fraction (HFpEF) means that the heart pumps enough blood to the body, but patients still have terrible symptoms. It is estimated to account for about 50% of all heart failure cases. Experts agree that impaired filling of the heart, perhaps due to "stiffness" of the heart muscle itself, critically underlies HFpEF. There is currently no clinical technique for measuring heart muscle (myocardial) stiffness; the very definition of "myocardial stiffness" remains poorly established. Consequently, the ability to study the mechanisms that underlie HFpEF is virtually non-existent, and limited treatment options will persist without significant advances. The objective of this project is to use an Equilibrium-Material-Stability (EMS) framework that couples patient-specific clinical MRI and heart pressure data in a computational model of the heart to diagnose changes in myocardial stiffness. The central hypothesis is that the new EMS framework for understanding the mechanisms of diastolic dysfunction in HFpEF will be more sensitive and outperform currently available approaches.
Read the detailed description
The study has three aims. The first aim of the project is to refine MRI techniques using "free-breathing" versus "breath-holding" measurements. Twenty-five normal volunteers will undergo MRI to refine "free-breathing" cardiac imaging and enable construction of patient-specific computer models of the heart. The second aim of the project is to validate and test the myocardial stiffness evaluation framework derived through the first objective in human subjects. Twenty-five normal volunteers will undergo MRI and the data from these images will be compared to specially constructed 3D printed models of the heart, enabling refinement of the EMS framework to separate structural stiffness from material stiffness. The third aim of the project is to measure changes in myocardial stiffness in patients with HFpEF. Thirty-three subjects with current diagnostic criteria for HFpEF will be evaluated at baseline and at six months to evaluate myocardial stiffness and cardiac MRI biomarkers. Specifically, this aim will establish the diagnostic sensitivity of the EMS framework with comparison to cardiac MRI biomarkers of increased stiffness, thereby providing mechanistic insight to one critical underlying cause of HFpEF.
- Being tested
- MRI (cardiac) off-label use gadolinium contrast (IND exempt), MRI (cardiac)
- Keywords
- diastolic dysfunction, mechanism, MRI magnetic resonance imaging, ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (cardiac) off-label use gadolinium contrast (IND exempt)Diagnostic test
Clinical MRI
MRI (cardiac)Diagnostic test
MRI without contrast
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 includes 25 healthy subjects recruited in Year 1 to undergo cardiac MRI without contrast. Receives: Diagnostic Test: MRI (cardiac) |
| Group 2 | Experimental | Group 2 includes 25 healthy subjects recruited in Year 2 to undergo cardiac MRI without contrast. Receives: Diagnostic Test: MRI (cardiac) |
| Group 3 | Experimental | Group 3 includes 33 patients with Heart Failure with Preserved Ejection Fraction (HFpEF) who will undergo cardiac MRI at baseline and at six months to assess diagnostic sensitivity of MRI measurement. Receives: Diagnostic Test: MRI (cardiac) off-label use gadolinium contrast (IND exempt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of the EMS framework with comparison to cardiac MRI biomarkers of increased stiffness, thereby providing mechanistic insight to one critical underlying cause of HFpEF.
Assess the diagnostic sensitivity of MRI method by analyzing baseline and six month longitudinal characteristics in myocardial stiffness measured in patients with HFpEF
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Jun 2018 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: The PI left the institution and closed the study prior to enrolling any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel Ennis, PhD, University of California, Los Angeles
- Investigators
- Daniel J Ennis, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340233
- Sponsor's protocol ID
- IRB#17-000695
- Other IDs
- 1R01HL131823-01A1
- Status last verified
- Apr 2019
- First submitted
- 8 Nov 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Framework for Understanding the Mechanism of Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT03340233
- Acronym / sponsor ID
- IRB#17-000695
- Keywords
- diastolic dysfunction, mechanism, MRI magnetic resonance imaging, ejection fraction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI left the institution and closed the study prior to enrolling any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 13 Nov 2017 (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.
Heart failure is a clinical syndrome marked by breathlessness, even at low levels of exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people in the United States. Heart failure with preserved ejection fraction (HFpEF) means that the heart pumps enough blood to the body, but patients still have terrible symptoms. It is estimated to account for about 50% of all heart failure cases. Experts agree that impaired filling of the heart, perhaps due to "stiffness" of the heart muscle itself, critically underlies HFpEF. There is currently no clinical technique for measuring heart muscle (myocardial) stiffness; the very definition of "myocardial stiffness" remains poorly established. Consequently, the ability to study the mechanisms that underlie HFpEF is virtually non-existent, and limited treatment options will persist without significant advances. The objective of this project is to use an Equilibrium-Material-Stability (EMS) framework that couples patient-specific clinical MRI and heart pressure data in a computational model of the heart to diagnose changes in myocardial stiffness. The central hypothesis is that the new EMS framework for understanding the mechanisms of diastolic dysfunction in HFpEF will be more sensitive and outperform currently available approaches.
Detailed description
The study has three aims. The first aim of the project is to refine MRI techniques using "free-breathing" versus "breath-holding" measurements. Twenty-five normal volunteers will undergo MRI to refine "free-breathing" cardiac imaging and enable construction of patient-specific computer models of the heart. The second aim of the project is to validate and test the myocardial stiffness evaluation framework derived through the first objective in human subjects. Twenty-five normal volunteers will undergo MRI and the data from these images will be compared to specially constructed 3D printed models of the heart, enabling refinement of the EMS framework to separate structural stiffness from material stiffness. The third aim of the project is to measure changes in myocardial stiffness in patients with HFpEF. Thirty-three subjects with current diagnostic criteria for HFpEF will be evaluated at baseline and at six months to evaluate myocardial stiffness and cardiac MRI biomarkers. Specifically, this aim will establish the diagnostic sensitivity of the EMS framework with comparison to cardiac MRI biomarkers of increased stiffness, thereby providing mechanistic insight to one critical underlying cause of HFpEF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: MRI (cardiac)Group 1 includes 25 healthy subjects recruited in Year 1 to undergo cardiac MRI without contrast. |
| Group 2 | Experimental | Diagnostic Test: MRI (cardiac)Group 2 includes 25 healthy subjects recruited in Year 2 to undergo cardiac MRI without contrast. |
| Group 3 | Experimental | Diagnostic Test: MRI (cardiac) off-label use gadolinium contrast (IND exempt)Group 3 includes 33 patients with Heart Failure with Preserved Ejection Fraction (HFpEF) who will undergo cardiac MRI at baseline and at six months to assess diagnostic sensitivity of MRI measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers
- 1. Healthy adults
- Patients with Heart Failure with Preserved Ejection Fraction
- Patient scheduled for catheterization at UCLA Medical Center
- Ejection fraction >/= 50%
Key exclusion criteria (10 listed)
- Healthy volunteers
- Known medical condition that impacts heart health
- Contraindications to MRI (e.g., pacemaker/ICD, or claustrophobia)
- Patients with Heart Failure with Preserved Ejection Fraction
- Contraindications to MRI (e.g., pacemaker/ICD, or 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 |
|---|---|---|
| MRI (cardiac) off-label use gadolinium contrast (IND exempt)Clinical MRI | Diagnostic test | Group 3 |
| MRI (cardiac)MRI without contrast | Diagnostic test | Group 1, Group 2 |
Primary outcome
The sensitivity of the EMS framework with comparison to cardiac MRI biomarkers of increased stiffness, thereby providing mechanistic insight to one critical underlying cause of HFpEF.
Time frame: Five years
Assess the diagnostic sensitivity of MRI method by analyzing baseline and six month longitudinal characteristics in myocardial stiffness measured in patients with HFpEF
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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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.
Daniel J Ennis, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI (cardiac) off-label use gadolinium contrast (IND exempt) and MRI (cardiac) in people with Heart Failure With Preserved Ejection Fraction and Healthy, run by University of California, Los Angeles 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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 1 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The sensitivity of the EMS framework with comparison to cardiac MRI biomarkers of increased stiffness, thereby providing mechanistic insight to one critical underlying cause of HFpEF. (time frame: Five 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 1 May 2019.