Clinical trial NCT04126018: Comparative Imaging Assessment of Valvular Heart Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valve Heart Disease
Aortic Stenosis
Aortic Regurgitation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in MRI Quantified LVEDVi
timeFrame: 6 months
measure: Change in MRI Quantified LVESVi
timeFrame: 6 months
measure: Change in MRI Quantified LV Strain
timeFrame: 6 months
measure: Change in MRI LVEF
timeFrame: 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire Answers
timeFrame: 6 Months
measure: Change in Physical Activity Questionnaire Answers
timeFrame: 6 Months
measure: All-cause mortality
timeFrame: 6 Months
measure: Development of class I or IIa indication for valve surgery
timeFrame: 6 Months
Secondary outcomes:
measure: Accuracy of echocardiography as compared with MRI
timeFrame: 6 Months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Deborah Kwon, M. D.
role: PRINCIPAL_INVESTIGATOR
References: