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Observational Study of Valvular Heart Disease Imaging

This study aims to compare different imaging methods for assessing valvular heart disease (problems with heart valves). Researchers are looking at how well various 2D and 3D echocardiography (ultrasound of the heart) techniques, including Doppler, PISA, VCA, and volumetric methods, compare to cardiac magnetic resonance (CMR) imaging. CMR measures how well the heart's pumping chambers (ventricles) are working and checks for scarring in the heart muscle (myocardial fibrosis). The study will enroll about 200 participants aged 18 to 90 who have suspected moderate or severe problems with their aortic or mitral valves. The main goals are to see how changes in heart chamber size and strain (how much the heart muscle stretches and contracts) measured by MRI change over 6 months. The study status is currently unclear.

Study design
This is an observational study with a planned enrollment of 200 participants. It is not a treatment study but rather compares different diagnostic imaging techniques.
What's involved
You would complete questionnaires at the start of the study. A follow-up visit is required 6-12 months later, which will include a non-contrast research cardiac MRI and more questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 to 12 months after their initial assessment.

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NCT04126018

Comparative Imaging Assessment of Valvular Heart Disease

Recruiting
Not specifiedAges 18–90Observational
The Cleveland Clinic
~200 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:MRI with strain measurementEchocardiography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in MRI Quantified LVEDVi
Measured over 6 months
+7 more outcomes measured

Conditions

Valve Heart Disease
Aortic Stenosis
Aortic Regurgitation

Explore related trials

Aortic Valve InsufficiencyAortic Valve StenosisMitral Valve Insufficiency

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Deborah Kwon, M. D. · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Deborah Kwon, M. D.
[email protected]
216-444-8526
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in MRI Quantified LVEDVi6 months

    10% Change from Baseline - units of measure cc/m2

  • Change in MRI Quantified LVESVi6 months

    15% Change from Baseline - units of measure cc/m2

  • Change in MRI Quantified LV Strain6 months

    5% Change from Baseline

  • Change in MRI LVEF6 Months

    5% Change from Baseline

  • Change in Kansas City Cardiomyopathy Questionnaire Answers6 Months

    Change in quality of life related to heart failure symptoms.

  • Change in Physical Activity Questionnaire Answers6 Months

    Change in physical activity level due to heart failure symptoms.

  • All-cause mortality6 Months

    number of patients expired

  • Development of class I or IIa indication for valve surgery6 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).