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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04067635
Other study ID # Pro00018490
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 25, 2018
Est. completion date June 2021

Study information

Verified date August 2019
Source The Methodist Hospital System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.


Description:

The transition from compensated to decompensated chronic primary mitral regurgitation remains poorly understood in the clinical setting. Changes at the myocardial tissue level, such as scar formation and decreased contractility, have been implicated in the end stage, decompensated phase of this disease entity.

Advances in cardiac MRI (CMR) have enabled non-invasive characterization of the myocardial tissue components, such as cardiomyocyte volume and extracellular matrix, and tissue contractility. These measures have been well validated in various cardiac pathologies with biopsy studies but only at single time points.

In this study, adults with isolated chronic primary regurgitation will be followed conservatively over at least a year to determine the natural progression of these CMR-derived markers over time and to investigate the prognostic potential of these markers for clinically assessed functional capacity and symptoms. These participants may elect to undergo any valvular intervention at the discretion of their treating clinical team.

Alongside this arm, similar adults with isolated chronic primary regurgitation will be recruited, who have elected upfront to undergo surgical repair. These patients will be similarly studied to determine reverse remodeling of these CMR-derived markers over time and to investigate the prognostic potential of these markers for the same clinical outcomes.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 116
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age =18 years

2. Isolated mitral regurgitation

1. of any primary mechanism and

2. of moderate-to-severe (Sellers 3+) or greater severity, assessed by any imaging modality (echocardiography, angiography, cardiac MRI)

3. Able to receive gadolinium-based contrast agent (estimated glomerular filtration rate >30 mL/min/1.73 m2, no prior allergy to gadolinium contrast agents)

Exclusion Criteria:

1. Refusal to consent

2. Pregnancy during the study

3. Hemodynamically or clinically unstable

4. Inability to undergo a CMR scan, which can include the following reasons: severe claustrophobia, ferromagnetic implants, implanted defibrillator, pacemaker, or abandoned pacemaker leads, cochlear implants, unable to lie flat

5. Other diseases known to influence myocardial fibrosis development (coronary artery disease, diabetes mellitus, uncontrolled hypertension, infiltrative cardiomyopathy, myocarditis, hypertrophic cardiomyopathy, any cardiac tumors, moderate or more valvular heart disease other than primary mitral valve regurgitation)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Houston Methodist Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Eric Y. Yang, MD PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cardiomyopathy symptom score Heart failure symptom scores will be tracked to monitor for changes in symptom burden at 2 subsequent timepoints. Scores are derived from a validated cardiomyopathy symptom patient-reported outcome measure instrument. The full name of the instrument is the Kansas City Cardiomyopathy Questionnaire Short Form (aka KCCQ-12) licensed by CV Outcomes, Inc. Only a complete score is recorded. The full range of scores scale from 0 to 100, with higher scores indicating lower symptom burden. Baseline, 6 (+/-3) months, >12 months
Primary Changes in distance measured on 6-Minute Walk Test Distance (meters) walked using a standardized 6-minute walk protocol will be tracked to monitor for changes in functional capacity at 2 subsequent timepoints. Baseline, 6 (+/-3) months, >12 months
Secondary Late gadolinium myocardial enhancement Semi-quantitative measure of left ventricular replacement fibrosis burden using cardiac MRI techniques with gadolinium-based contrast agents. The quantity measured is the percentage of left ventricular myocardial volume found to have late gadolinium enhancement. Baseline, 6 (+/-3) months, >12 months
Secondary Myocardial extracellular volume fraction Extracellular volume fraction measure derived using T1 mapping from cardiac MRI techniques. The quantity measured is the proportion of extracellular matrix volume to cardiomyocyte volume. Baseline, 6 (+/-3) months, >12 months
Secondary Cardiac Morphology Cardiac MRI measures from cine images of cardiac chamber dimensions (milliliters) at end-diastolic and end-systolic cardiac phases. Baseline, 6 (+/-3) months, >12 months
Secondary Cardiovascular Flow Volumes Cardiovascular MRI measures from phase contrast cine images of flow (mL/s) through major vessels. The flow quantity is integrated over a cardiac cycle to produce a volume (mL) per beat. Baseline, 6 (+/-3) months, >12 months
Secondary Ventricular Mass Cardiac MRI measures of left ventricular myocardial mass (grams) Baseline, 6 (+/-3) months, >12 months
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