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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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22 May 2023 |
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Main ID: |
NCT04133532 |
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Date of registration:
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16/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
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Scientific title:
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Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy |
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Date of first enrolment:
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March 5, 2020 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04133532 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Czechia
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Contacts
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Name:
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Josef Veselka, 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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Motol University Hospital, Department of Cardiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients post alcohol septal ablation
- Pressure gradient in left ventricular outflow tract <30 mmHg
- Written consent to participate
Exclusion Criteria:
- History of atrial fibrillation
- Symptoms of Class III or IV of New York Heart Association functional classification
- Permanent pacemaker implant
- Age above 75
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertrophic Cardiomyopathy
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Intervention(s)
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Drug: Metoprolol
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Primary Outcome(s)
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Change in exercise tolerance with and without metoprolol
[Time Frame: At baseline, after three months of metoprolol medication, after three months without metoprolol medication]
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Secondary Outcome(s)
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Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol
[Time Frame: After three months of metoprolol medication, after three months without metoprolol medication]
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Change in left ventricular diastolic function at rest with and without metoprolol
[Time Frame: After three months of metoprolol medication, after three months without metoprolol medication]
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Change of concentration of a biomarker of myocardial injury with and without metoprolol
[Time Frame: After three months of metoprolol medication, after three months without metoprolol medication]
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Change of concentration of biomarker of heart failure with and without metoprolol
[Time Frame: After three months of metoprolol medication, after three months without metoprolol medication]
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Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire
[Time Frame: After three months of metoprolol medication, after three months without metoprolol medication]
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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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