Health TrialsbyHealthPanel

Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

ConditionsAortic RegurgitationMitral RegurgitationAortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Cleveland Clinic

About this trial

This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.

The aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-90 years of age

Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.

Disqualifiers

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

Trial population

Patients with at least moderate Aortic Stenosis or Aortic Regurgitation who are scheduled for a surgical repair or replacement of their aortic valve.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CMR

    Diagnostic test

    CMR (with contrast at baseline and non-contrast at follow-up)

  • Quality of Life Questionnaire

    Other intervention

    Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Intervention2 interventions

Trial outcomes

Primary outcomes

1

Change in LV Dilation and/or change in LVEF

Significant change in LV remodeling will be defined as a change in EF by 10 units (reverse remodeling is defined at least 10 unit decrease) or change in LV end-diastolic/systolic volume by 10% (Reverse remodeling is defined as at least decrease in LV end-diastolic/systolic volume by 10%

Time frame
6-12 months

Secondary outcomes

1

Change in Aortic Regurgiation

Change in Aortic Regurgitant Fraction will be modeled as a continuous variable, as well as a threshold change of 5 points or more, as measured by cardiac MRI

Time frame
6-12 months
2

Change in BNP

NT-proBNP will be modeled as a continuous variable as well as a threshold change of 30% or decrease to level \< 1000

Time frame
6-12 months
3

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

KCCQ will be modeled as a continuous variable, as well as a threshold change of 5 points or more. KCCQ scoring transforms Likert-scale answers into 0-100 scores (higher is better) for domains like Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations, with a summary score reflecting overall health, where 0-24 is very poor, 25-49 poor/fair, 50-74 fair/good, and 75-100 good/excellent health.

Time frame
6-12 months
4

6 minute walk test

6 minute walk test will be modeled as a continuous variable as well as a threshold change of 30meters or more

Time frame
6-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
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