Ignite Creation Date:
2024-05-06 @ 2:17 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010905
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2013-12-06
Brief Title:
Right Ventricular Dysfunction in Tetralogy of Fallot Inhibition of the Renin-angiotensin-aldosterone System
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Right Ventricular Dysfunction in Tetralogy of Fallot Inhibition of the Renin-angiotensin-aldosterone System
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Redefine
Brief Summary:
Rationale The prevalence of adult patients with congenital heart disease CHD has steadily increased over the last decades due to the advances in cardiac surgery A large number of these patients cope with right ventricular RV volume or pressure overload largely caused by residual lesions after cardiac surgery in childhood Previous RV overload due to pulmonary regurgitation in Tetralogy of Fallot TOF can lead to RV dysfunction These findings warrant close surveillance of RV function and adequate and evidence-based pharmacological therapy to reduce both morbidity and mortality in this young patient group The renin-angiotensin-aldosterone system RAAS is activated in patients with ventricular failure irrespective of the effected left or right ventricle Angiotensin converting enzyme ACE inhibitors and angiotensin II receptor blockers ARBs are drugs which act as inhibitors of RAAS Previously large trials have demonstrated the beneficial effect of angiotensin converting enzyme ACE inhibitors on morbidity and mortality in patients with acquired left ventricular LV dysfunction ARBs have a similar effect as ACE inhibitors in patients with acquired LV dysfunction but discontinuation because of side effects such as cough is less frequent In TOF patients with RV overload due to pulmonary regurgitation pulmonary valve replacement leads to a decrease in RV size and pulmonary regurgitation Current guidelines advise empiric use of RAAS inhibitors for right ventricular dysfunction in adult patients with congenital heart disease However the actual effect of RAAS inhibition on right ventricular dysfunction in adult TOF patients without severe valvular lesions has not been sufficiently investigated Therefore we set-up the proposed study and hypothesize that ARBs have a beneficial effect on RV ejection fraction in adult TOF patients with RV dysfunction without severe valvular lesions
Objective to improve RV ejection fraction in adult TOF patients with RV dysfunction without severe valvular lesions
Study design a prospective multicenter double-blind randomized placebo-controlled trial Follow up two years Study population adult patients with Tetralogy of Fallot with right ventricular dysfunction defined as right ventricular ejection fraction 50 and without severe valvular lesions Intervention patients are randomized to receive either losartan 150 mg once daily or placebo in the same regimen Main study parametersendpoints the primary endpoint is difference in change in RV ejection fraction determined by cardiovascular magnetic resonance imaging CMR between the treatment and the control group at two years follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness All investigations except blood analysis are non-invasive and free of risk The burden for the patients mainly consists of the time that is consumed by the visits to the clinic At these visits time will be consumed by history taking and physical investigation 15 minutes quality of life score 15 minutes laboratory tests 6 times venopuncture total amount of blood withdrawn approximately 90ml Cardiopulmonary exercise testing 1hour echocardiography 15 minutes and CMR 45 minutes are part of regular medical care Adverse effects from losartan are usually limited and consist of dizziness due to hypotension renal impairment hyperkalemia and liver impairment We expect no change or an increase in RV function in the intervention group compared to the control group over the two-year follow up period which would be a great benefit for this young study population
Objective to improve RV ejection fraction in adult TOF patients with RV dysfunction without severe valvular lesions
Study design a prospective multicenter double-blind randomized placebo-controlled trial Follow up two years Study population adult patients with Tetralogy of Fallot with right ventricular dysfunction defined as right ventricular ejection fraction 50 and without severe valvular lesions Intervention patients are randomized to receive either losartan 150 mg once daily or placebo in the same regimen Main study parametersendpoints the primary endpoint is difference in change in RV ejection fraction determined by cardiovascular magnetic resonance imaging CMR between the treatment and the control group at two years follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness All investigations except blood analysis are non-invasive and free of risk The burden for the patients mainly consists of the time that is consumed by the visits to the clinic At these visits time will be consumed by history taking and physical investigation 15 minutes quality of life score 15 minutes laboratory tests 6 times venopuncture total amount of blood withdrawn approximately 90ml Cardiopulmonary exercise testing 1hour echocardiography 15 minutes and CMR 45 minutes are part of regular medical care Adverse effects from losartan are usually limited and consist of dizziness due to hypotension renal impairment hyperkalemia and liver impairment We expect no change or an increase in RV function in the intervention group compared to the control group over the two-year follow up period which would be a great benefit for this young study population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None