- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624934
Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis
Clinical Predictive Value of Podocan and Wnt Pathway Regulatory Molecules on Maladaptive Left Ventricular Response in Aortic Stenosis
Study Overview
Status
Conditions
Detailed Description
Valvular heart disease is a common clinical indication to assess patients with cardiac MRI. Cardiac MRI is comprehensive study that uses multiple imaging sequences.Cardiac MRI is indicated to image native and prosthetic aortic valves. Planimetry of the aortic valve is valuable for determination of the severity of aortic stenosis. Cardiac MRI is the most accurate and reproducible imaging modality to assess left ventricular function and mass. Left ventricular (LV) function is a primary determinant of outcomes following aortic valve replacement. LV mass is increased in severe aortic stenosis. Variations in the morphology of hypertrophy in response to aortic stenosis have been detected by cardiac MRI. Cardiac MRI is commonly used to assess aortic stenosis in the context of discordant information from alternative imaging modalities and low gradient aortic stenosis.
It is expected that 100 participants will be enrolled in the study over 24 months. This is sample size was agreed upon after discussion with the statistics team.
Patients who agree to participate will provide informed consent prior to their cardiac MRI. A 6 minute walk test to measure baseline functional status will be done after consent, preferably just prior to reporting to the MRI suite for their scheduled test. Standard cardiac MRI will be obtained. All patients having a cardiac MRI have an IV line placed as normal procedure. When the line has been placed, prior to contrast infusion (if applicable)or other medication administration, blood samples will be collected to test for circulatory Podocan and Wnt pathway molecules. Approximately 20 cc will be drawn in total. All specimens will be sent to the experimental lab of Dr. Paul Klotman at Baylor Medical Center. All of the Podocan & Wnt pathway effectory molecules assays will be completed by Dr. Klotman's lab.
The following measurements will be collected from the cardiac MRI:
LV end diastolic (ED) volume: ml LV ED index: ml/m2 LV end systolic (ES) volume: ml LV ES index: ml/m2 LV ejection fraction (EF): % LV Stroke Volume: ml LV Stroke Index: ml/m2 LV Cardiac Output: L/min LV Cardiac Index: L/min/M2 LV Mass: g LV Mass index: g/m2
At 12 months post procedure the following information will be collected from the participants' charts for endpoint analysis:
All cause mortality Cardiac mortality Hospital admissions for valvular disease related clinical events such as congestive heart failure, angina, syncope Valve replacement surgery
Patients who do undergo valve replacement surgery during the 12 month follow up period and are scheduled to undergo a post-op follow up cardiac MRI (expected to be at 9-12 months post-op) will be asked to provide additional blood samples to test for circulatory Podocan and Wnt pathway molecules at the time of the MRI.
Each participant's chart will be reviewed at the time of enrollment and the following variables will be abstracted from the medical record:
age, gender, ethnicity, Most recent Ht, Wt, BP, Heart Rate BMI Tobacco use/history Alcohol use/ history Comorbidities
- Hypertension
- Hyperlipidemia
- Diabetes
- Chronic Kidney Disease
- Cancer
- CAD
Info from previous echocardiogram:
- Ejection fraction
- Valve area
- Gradient
Info from previous cardiac cath (if done):
- Presence/absence of coronary stenosis
- Location & degree of stenosis
- Aortic valve area
- Calculation of valve area
Info from previous ECG:
- Rhythm
- Left Ventricular Hypertrophy Medications
Laboratory data:
- Lipids
- Chemistries
- Complete Blood Count
- Hemoglobin A1C
- Troponin
- B-type Natriuretic Peptide
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Cooperstown, New York, United States, 13326
- Bassett Healthcare Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 or greater
- Scheduled for Cardiac MRI
- Patients with known aortic valve area of less than 1 cm² on echocardiogram
- Able to provide informed consent
- Ambulatory and expected to be able to complete 6 minute walk test
Exclusion Criteria:
- Other significant (moderate or severe) valvular heart disease
- Unable to complete 6 minute walk test (ex. Wheelchair bound)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Podocan level
Time Frame: Day 1
|
All patients having a cardiac MRI have an IV line placed as normal procedure.
When the line has been placed, prior to contrast infusion (if applicable)or other medication administration, blood samples will be collected to test for circulatory Podocan .
|
Day 1
|
Wnt Pathway molecule levels
Time Frame: Day 1
|
All patients having a cardiac MRI have an IV line placed as normal procedure.
When the line has been placed, prior to contrast infusion (if applicable)or other medication administration, blood samples will be collected to test for circulatory Wnt pathway molecules
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Podocan level
Time Frame: 18 months
|
Any previously evaluated participants who go on to have aortic valve replacement surgery, will have repeat blood sampling for Podocan levels at time of 9-12 month post op assessment.
|
18 months
|
Wnt Pathway molecule levels
Time Frame: 18 months
|
Any previously evaluated participants who go on to have aortic valve replacement surgery, will have repeat blood sampling for Wnt pathway molecule levels at time of 9-12 month post op assessment.
|
18 months
|
6 minute walk test
Time Frame: Day 1
|
To assess whether circulatory podocan is associated with improved functional capacity of patients with AS, the relationship between circulatory podocan and a six minute walk test conducted at the time of cardiac MRI will be assessed
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: D Katz, MD, Bassett Healthcare
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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