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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 August 2023 |
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Main ID: |
NCT03422770 |
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Date of registration:
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18/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
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Scientific title:
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Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis |
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Date of first enrolment:
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January 9, 2018 |
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Target sample size:
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132 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03422770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Brage Høyem Amundsen, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Norwegian University of Science and Technology |
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Name:
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Svend Aakhus, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Norwegian University of Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Able to undergo protocolled investigations
- Patients: Mild, moderate or severe AS
Exclusion Criteria:
- Renal insufficiency
- Previously myocardial infarction (ECG, echocardiogram or hospital record)
- Severe valvular heart disease (except patients)
- Other cardiac disease known to cause myocardial fibrosis
- Severe hypertension
- Other medical conditions deterring protocolled investigation and follow-up
- Other medical conditions affecting 5-yrs prognosis (cancer, pulmonary disease)
- Severely reduced image-quality (echocardiography and MRI)
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Valve Stenosis
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Myocardial Fibrosis
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Intervention(s)
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Diagnostic Test: Blood test
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Diagnostic Test: 6 min walking test
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Diagnostic Test: ECG and Holter-ECG
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Diagnostic Test: Echocardiography
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Diagnostic Test: MRI
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Primary Outcome(s)
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Cardiovascular morbidity and mortality
[Time Frame: 1 + 3 year]
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Secondary Outcome(s)
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Time of first re-hospitalisation
[Time Frame: 3 years]
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Cardiac diastolic function
[Time Frame: 1 year.]
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Cardiac systolic function
[Time Frame: 1 year.]
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All cause mortality
[Time Frame: 3 years]
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Secondary ID(s)
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2017/1068
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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