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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: EUCTR
Last refreshed on: 27 October 2014
Main ID:  EUCTR2013-002091-41-NL
Date of registration: 05/11/2013
Prospective Registration: Yes
Primary sponsor: Academisch medisch centrum
Public title: 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
Scientific title: Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system - Redefine trial
Date of first enrolment: 09/10/2014
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002091-41
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Mulder   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 00312056668687
Email: b.j.mulder@amc.uva.nl
Affiliation:  Academisch medisch centrum
Name: Mulder   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 00312056668687
Email: b.j.mulder@amc.uva.nl
Affiliation:  Academisch medisch centrum
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
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.
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

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

Primary Outcome(s)
Timepoint(s) of evaluation of this end point: End of study
Primary end point(s): change in the right ventricular ejection fraction (on CMR or CT)
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
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
Secondary Outcome(s)
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
Timepoint(s) of evaluation of this end point: end of study
Secondary ID(s)
03618
Source(s) of Monetary Support
ICIN
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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