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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. |
Register:
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EUCTR |
Last refreshed on:
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27 October 2014 |
Main ID: |
EUCTR2013-002091-41-NL |
Date of registration:
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05/11/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Research into the effect of the drug losartan in adult patients with a reduced function of the right cardiac chamber and a cardiac birth defect
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Scientific title:
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Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system - Redefine trial |
Date of first enrolment:
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09/10/2014 |
Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002091-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Mulder
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
Netherlands |
Telephone:
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00312056668687 |
Email:
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b.j.mulder@amc.uva.nl |
Affiliation:
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Academisch medisch centrum |
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Name:
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Mulder
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Address:
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Meibergdreef 9
1105 AZ
Amsterdam
Netherlands |
Telephone:
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00312056668687 |
Email:
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b.j.mulder@amc.uva.nl |
Affiliation:
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Academisch medisch centrum |
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Key inclusion & exclusion criteria
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Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: adult age and mentally competent; and Tetralogy of Fallot; and right ventricular dysfunction, defined as right ventricular ejection fraction <50% as measured by Cardiovascular Magnetic Resonance Imaging (CMR) or CT. Without severe pulmonary stenosis, pulmonary regurgitation or tricuspid regurgitation as measured by CMR or echocardiography. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Incapable of giving informed consent - Hypersensitivity to valsartan or any of its help substances - Hypersensitivity to intravenous contrast agent - Previous or current angioedema whether or not in relation to the use of an ACE inhibitor or ARB - Known bilateral renal artery stenosis - Current symptomatic hypotension - Estimated glomerular filtration rate of 30 ml/min or lower - Plasma potassium level > 5,5 mmol/L - Moderate to severe liver disease: Child Pugh class B or C - Raised plasma transaminases level > three times upper normal limit - Current treatment of hypertension with an ACE-inhibitor or ARB, which cannot be discontinued - Pregnant or nursing women - Desire to have children within the study period - Both contra indication to undergoe CMR AND hypersenisitivty to intravenous contrast agent
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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To study the effect of losartan in adult patients with Tetralogy of Fallot and right ventricular dysfunction, defined as right ventricular ejection fraction <50%. Without severe valvular lesions.
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Trade Name: Losartan Product Name: Losartan Pharmaceutical Form: Capsule, hard INN or Proposed INN: Losartan Potassium CAS Number: 124750-99-8 Current Sponsor code: losartan Other descriptive name: LOSARTAN POTASSIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: End of study
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Primary end point(s): change in the right ventricular ejection fraction (on CMR or CT)
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Main Objective: To determine whether the use of angiotensin receptor blockers improves the right ventricular ejection fraction in adult patients with RV dysfunction due to tetralogy of Fallot compared with placebo
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Secondary Objective: deterTomine whether the use of angiotensin receptor blockers chances:
1. (RV) and LV volumes mass, and ejection-fraction 2. hospitalization for heart failure 3. death 4. pulmonary regurgitation 5. the prevalence of supra ventricular arrhythmias 6. the serum neurohormone levels 7. NYHA class? 8. quality of life? 9. VO2max 10. microRNAs
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Secondary Outcome(s)
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Secondary end point(s): change in: 1. (RV and) LV volumes mass, and ejection-fraction 2. hospitalization for heart failure 3. death 4. pulmonary regurgitation 5. the prevalence of supra ventricular arrhythmias 6. the serum neurohormone levels 7. NYHA class? 8. quality of life? 9. VO2 max 10. microRNAs
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Timepoint(s) of evaluation of this end point: end of study
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Source(s) of Monetary Support
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ICIN
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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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