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Comparative Imaging Assessment of Valvular Heart Disease

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ClinicalTrials.gov Identifier: NCT04126018
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Kwon, MD, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment
Valve Heart Disease Aortic Stenosis Aortic Regurgitation Diagnostic Test: MRI with strain measurement Diagnostic Test: Echocardiography

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 month follow-up is required and will include an abbreviated non-contrast research cardiac MRI and subject questionnaires. At 1 year, subject questionnaires will again be required.

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
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.
Diagnostic Test: MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Diagnostic Test: Echocardiography
Doppler, PISA, VCA, volumetric method as performed during 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.
Diagnostic Test: MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Diagnostic Test: Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography

Aortic Stenosis
Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.
Diagnostic Test: MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Diagnostic Test: Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography

Patients referred for CRT Implantation
Patients who meet clinical guideline criteria for CRT implantation with EF < 40%
Diagnostic Test: MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Diagnostic Test: Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography




Primary Outcome Measures :
  1. Change in MRI Quantified LVEDVi [ Time Frame: 6 months ]
    10% Change from Baseline - units of measure cc/m2

  2. Change in MRI Quantified LVESVi [ Time Frame: 6 months ]
    15% Change from Baseline - units of measure cc/m2

  3. Change in MRI Quantified LV Strain [ Time Frame: 6 months ]
    5% Change from Baseline

  4. Change in MRI LVEF [ Time Frame: 6 Months ]
    5% Change from Baseline

  5. Change in Kansas City Cardiomyopathy Questionnaire Answers [ Time Frame: 6 Months ]
    Change in quality of life related to heart failure symptoms.

  6. Change in Physical Activity Questionnaire Answers [ Time Frame: 6 Months ]
    Change in physical activity level due to heart failure symptoms.

  7. All-cause mortality [ Time Frame: 6 Months ]
  8. 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).


Secondary Outcome Measures :
  1. Accuracy of echocardiography as compared with MRI [ Time Frame: 6 Months ]
    Comparison of MRI measurements based on standard of care echocardiography.


Biospecimen Retention:   Samples With DNA
As part of an optional sub study, subjects will be asked to provide blood samples at the baseline visit. Up to 5 tablespoons (75ml) of blood will be drawn. Genomic analyses will be run on the samples to look for biomarkers which may correlate with the development of myocardial fibrosis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126018


Contacts
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Contact: Deborah Kwon, M. D. 216-444-8526 kwond@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Deborah Kwon, M. D.    216-444-8526    kwond@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Deborah Kwon, M. D. The Cleveland Clinic

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Responsible Party: Deborah Kwon, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04126018     History of Changes
Other Study ID Numbers: 19-549
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction