Valve Heart DiseaseNCT04126018
Comparative Imaging Assessment of Valvular Heart Disease
An observational study of Valve Heart Disease and Aortic Stenosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation
- What is being tested?
- MRI with strain measurement and Echocardiography
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 31 Dec 2027
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected chronic AS, AR, MR or heart failure with reduced ejection fraction being evaluated for CRT implantation referred for clinically indicated CMR and echocardiography by their cardiologists.. CMR and echocardiography will be clinically indicated in this study group.
Who may be able to join
- Age 18-90 years of age
- Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.
- Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction
Who cannot join
- Acute traumatic cardiac injury
- Aortic dissection or aortic root rupture
- Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
- Presence of A-V fistula or intracardiac shunts
- Any contraindications to CMR
- Moderate or severe dysfunction in multiple valves
- Patients with significant claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Deborah Kwon, M. D., 216-444-8526, kwond@ccf.org
Richard Grimm, MD
About this study
Official title: Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.
Read the detailed description
The objective of this study is to compare the accuracy of 3D TTE to 2D TTE in assessing the severity of valvular heart disease in patients with aortic stenosis, aortic regurgitation, and mitral valve regurgitation by comparing this to the reference standard of cardiac magnetic resonance (CMR) in subjects with different etiologies and mechanisms of valvular lesions and to the integrative method of valvular lesion grading as recommended by inter-societal guidelines. Another objective is to assess prevalence of focal and diffuse myocardial fibrosis as assessed by CMR in patients with aortic stenosis, aortic regurgitation and mitral regurgitation. In addition, the investigators aim to determine whether severity of myocardial fibrosis predicts onset of symptoms, referral for valve surgery and adverse ventricular remodeling. The investigators also aim to look at patients who will be undergoing CRT implant to predict their response to therapy.
At baseline, the Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire will be completed. A 6-12 month follow-up is required and will include an abbreviated non-contrast research cardiac MRI and subject questionnaires.
Other follow-up will include using electronic medical records and the Social Security Death Index database for outcomes such as death, hospitalization for heart failure, mitral or aortic valve interventions and cardiovascular death.
Select patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment. Approximately 40 subjects will be included in this substudy.
Additional exclusion criteria for this substudy:
- Unable to pedal a supine bicycle
- Require supplemental oxygen
During the exercise stress MRI, patients will be asked to cycle on a supine bike that will be mounted on the MRI platform. During this test, a caregiver will be present. An electrocardiogram (ECG) will be used to obtain tracings of cardiac activity. Respirations, blood pressure, and heart rate are also monitored during exercise. The test is continued until peak exercise level or target heart rate is achieved. As soon as the exercise portion is complete, MRI images will be acquired. When the test is complete, patients will be monitored until ECG, heart rate, and breathing have returned to baseline. Patients will be assessed for symptoms such as chest pain, dyspnea, leg pain, dizziness, or fatigue and may be given medications or instructed to stop the test early as necessary.
- Conditions
- Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation
- Being tested
- MRI with strain measurement, Echocardiography
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with strain measurementDiagnostic test
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
EchocardiographyDiagnostic test
Doppler, PISA, VCA, volumetric method as performed during echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Regurgitation | Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam. Receives: Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography | |
| Aortic Valve Regurgitation | Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam. Receives: Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography | |
| Aortic Stenosis | Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam. Receives: Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography | |
| Patients referred for CRT Implantation | Patients who meet clinical guideline criteria for CRT implantation with EF < 40% Receives: Diagnostic Test: MRI with strain measurement; Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MRI Quantified LVEDVi
10% Change from Baseline - units of measure cc/m2
Measured: 6 months
Change in MRI Quantified LVESVi
15% Change from Baseline - units of measure cc/m2
Measured: 6 months
Change in MRI Quantified LV Strain
5% Change from Baseline
Measured: 6 months
Change in MRI LVEF
5% Change from Baseline
Measured: 6 Months
Change in Kansas City Cardiomyopathy Questionnaire Answers
Change in quality of life related to heart failure symptoms.
Measured: 6 Months
Change in Physical Activity Questionnaire Answers
Change in physical activity level due to heart failure symptoms.
Measured: 6 Months
All-cause mortality
number of patients expired
Measured: 6 Months
Development of class I or IIa indication for valve surgery
The recommended indications for surgery include: development of symptoms, LV dysfunction (LV end-systolic diameter ≥45 mm or LV ejection fraction ≤60%), and new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary artery pressure >50 mm Hg at rest).
Measured: 6 Months
Secondary outcomes (1)
Accuracy of echocardiography as compared with MRI
Comparison of MRI measurements based on standard of care echocardiography.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start23 Aug 2019
- Primary completion31 Dec 2027 (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 Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Kwon, MD, The Cleveland Clinic
- Investigators
- Deborah Kwon, M. D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126018
- Sponsor's protocol ID
- 19-549
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2019
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
- ClinicalTrials.gov ID
- NCT04126018
- Acronym / sponsor ID
- 19-549
- Conditions
- Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Oct 2019 (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.
The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.
Detailed description
The objective of this study is to compare the accuracy of 3D TTE to 2D TTE in assessing the severity of valvular heart disease in patients with aortic stenosis, aortic regurgitation, and mitral valve regurgitation by comparing this to the reference standard of cardiac magnetic resonance (CMR) in subjects with different etiologies and mechanisms of valvular lesions and to the integrative method of valvular lesion grading as recommended by inter-societal guidelines. Another objective is to assess prevalence of focal and diffuse myocardial fibrosis as assessed by CMR in patients with aortic stenosis, aortic regurgitation and mitral regurgitation. In addition, the investigators aim to determine whether severity of myocardial fibrosis predicts onset of symptoms, referral for valve surgery and adverse ventricular remodeling. The investigators also aim to look at patients who will be undergoing CRT implant to predict their response to therapy.
At baseline, the Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire will be completed. A 6-12 month follow-up is required and will include an abbreviated non-contrast research cardiac MRI and subject questionnaires.
Other follow-up will include using electronic medical records and the Social Security Death Index database for outcomes such as death, hospitalization for heart failure, mitral or aortic valve interventions and cardiovascular death.
Select patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment. Approximately 40 subjects will be included in this substudy.
Additional exclusion criteria for this substudy:
- Unable to pedal a supine bicycle
- Require supplemental oxygen
During the exercise stress MRI, patients will be asked to cycle on a supine bike that will be mounted on the MRI platform. During this test, a caregiver will be present. An electrocardiogram (ECG) will be used to obtain tracings of cardiac activity. Respirations, blood pressure, and heart rate are also monitored during exercise. The test is continued until peak exercise level or target heart rate is achieved. As soon as the exercise portion is complete, MRI images will be acquired. When the test is complete, patients will be monitored until ECG, heart rate, and breathing have returned to baseline. Patients will be assessed for symptoms such as chest pain, dyspnea, leg pain, dizziness, or fatigue and may be given medications or instructed to stop the test early as necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Regurgitation | – | Diagnostic Test: MRI with strain measurement, Diagnostic Test: EchocardiographyPatients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam. |
| Aortic Valve Regurgitation | – | Diagnostic Test: MRI with strain measurement, Diagnostic Test: EchocardiographyPatients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam. |
| Aortic Stenosis | – | Diagnostic Test: MRI with strain measurement, Diagnostic Test: EchocardiographyPatients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam. |
| Patients referred for CRT Implantation | – | Diagnostic Test: MRI with strain measurement, Diagnostic Test: EchocardiographyPatients who meet clinical guideline criteria for CRT implantation with EF < 40% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected chronic AS, AR, MR or heart failure with reduced ejection fraction being evaluated for CRT implantation referred for clinically indicated CMR and echocardiography by their cardiologists.. CMR and echocardiography will be clinically indicated in this study group.
Key inclusion criteria (3 listed)
- Age 18-90 years of age
- Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.
- Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction
Key exclusion criteria (7 listed)
- Acute traumatic cardiac injury
- Aortic dissection or aortic root rupture
- Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
- Presence of A-V fistula or intracardiac shunts
- Any contraindications to CMR
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 with strain measurementCMR measurements of left and right ventricular systolic function strain and myocardial fibrosis | Diagnostic test | Aortic Stenosis, Aortic Valve Regurgitation, Mitral Valve Regurgitation, Patients referred for CRT Implantation |
| EchocardiographyDoppler, PISA, VCA, volumetric method as performed during echocardiography | Diagnostic test | Aortic Stenosis, Aortic Valve Regurgitation, Mitral Valve Regurgitation, Patients referred for CRT Implantation |
Primary outcome
Change in MRI Quantified LVEDVi
Time frame: 6 months
10% Change from Baseline - units of measure cc/m2
Change in MRI Quantified LVESVi
Time frame: 6 months
15% Change from Baseline - units of measure cc/m2
Change in MRI Quantified LV Strain
Time frame: 6 months
5% Change from Baseline
Change in MRI LVEF
Time frame: 6 Months
5% Change from Baseline
Change in Kansas City Cardiomyopathy Questionnaire Answers
Time frame: 6 Months
Change in quality of life related to heart failure symptoms.
Change in Physical Activity Questionnaire Answers
Time frame: 6 Months
Change in physical activity level due to heart failure symptoms.
All-cause mortality
Time frame: 6 Months
number of patients expired
Development of class I or IIa indication for valve surgery
Time frame: 6 Months
The recommended indications for surgery include: development of symptoms, LV dysfunction (LV end-systolic diameter ≥45 mm or LV ejection fraction ≤60%), and new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary artery pressure >50 mm Hg at rest).
1 secondary outcome
Accuracy of echocardiography as compared with MRI
Time frame: 6 Months
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 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Valve Heart Disease
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
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
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
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.
Deborah Kwon, M. D. principal investigator
The Cleveland Clinic
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 Valve Heart Disease and Aortic Stenosis, run by The Cleveland Clinic 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Jan 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?
Contact Deborah Kwon, M. D. (216-444-8526, kwond@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MRI Quantified LVEDVi (time frame: 6 months). The study lists 8 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 13 Jan 2026.