Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2016
• Main ID: NCT02010905
• Date of registration: 06/12/2013
• Prospective Registration: No
• Primary sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Public title: Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System Redefine
• Scientific title: Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System
• Date of first enrolment: December 2013
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02010905
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: J.P. Bokma

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% or lower as
measured by Cardiovascular Magnetic Resonance Imaging (CMR). Not more than moderate
tricuspid or pulmonary regurgitation or more than moderate pulmonary stenosis as measured
by CMR or echocardiography.

Exclusion Criteria:

- Incapable of giving informed consent

- Hypersensitivity to losartan or any of its help substances

- Contraindications for CMR

- 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 of 5,5 mmol/L or higher

- Moderate to severe liver disease: Child Pugh class B or C

- Raised plasma transaminases level more than three times upper normal limit

- Current treatment of hypertension with an ACE-inhibitor or ARB, which cannot be
discontinued

- Current treatment with potassium chloride, trimethoprim, tacrolimus or cyclosporine
which cannot be discontinued

- Pregnant or nursing women

- Desire to have children within the study period



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ventricular Dysfunction, Right

Tetralogy of Fallot

Heart Defects, Congenital

Intervention(s)

Drug: Losartan

Drug: Placebo

Primary Outcome(s)

Right ventricular ejection fraction [Time Frame: two years]

Secondary Outcome(s)

pulmonary regurgitation (CMR and echocardiography) [Time Frame: two years]

Quality of life (SF 36 and SQUASH) [Time Frame: two years]

LV EF (CMR) [Time Frame: two years]

RV volumes (CMR) [Time Frame: two years]

the prevalence of (supra) ventricular arrhythmias [Time Frame: within two years]

echocardiographic parameters for RV and LV function [Time Frame: one year and two years]

RV mass (CMR) [Time Frame: two years]

LV mass (CMR) [Time Frame: two years]

maximal exercise capacity (VO2 max) [Time Frame: two years]

serum Galectin-3 levels [Time Frame: two years]

aortic root diameter (CMR and echocardiography) [Time Frame: two years]

circulating microRNA's [Time Frame: two years]

death [Time Frame: two years]

hospitalization for heart failure [Time Frame: two years]

LV volumes (CMR) [Time Frame: two years]

NYHA class [Time Frame: two years]

the serum ntproBNP levels [Time Frame: one year and two years]

Secondary ID(s)

NL44943.018.13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Interuniversity Cardiology Institute of the Netherlands