Evaluation of the effect from ACE inhibition on body fluid regulation in children with a Fontan circulation (a circulation in which it lacks a heart chamber that pumps the blood througt the lung circulation).

ACE inhibition in Fontan patients: its effect on body fluid regulation. - Evaluation of ACE inhibition in Fontan patients (SAFE)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004433-24-NL

Enrollment

Registered

2017-02-22

Start date

2017-05-17

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with univentricular hearts palliated by the Fontan procedure

Interventions

Trade Name: Renitec: Enalapril Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Fontan patiënts Patiënts from 8 until 18 years old Are the trial subjects under 18? yes Number of subjects for this age range: 92 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Fontan patients who already use enalapril

Design outcomes

Primary

Measure	Time frame
Main Objective: -To treat Fontan patients for 3 months with the ACE inhibitor enalapril and compare a set of cardiovascular measurements before and after treatment in order to study its effect on the cardiovascular system in Fontan patients. ;Secondary Objective: -To assess autonomic parasympathetic and sympathetic function as well as vascular function in a population of patients with univentricular hearts palliated by the Fontan procedure and compare it with the results in healthy subjects. -To assess the effects of central fluid depletion by means of a passive head-up-tilt test and central fluid loading by passive leg raising on cardiac output, aortic distensibility and hepatic venous blood flow patterns in a group of patients with a Fontan circulation and compare it with the results in healthy controls. -To correlate the above mentioned results with the results of a symptom limited maximal exercise test. -To study the effect of a reversible fluid challenge and fluid depletion on cardiovascular parameters before and after a period of enalapril treatment in order to study changes in fluid susceptibility in Fontan patients. ;Primary end point(s): - Echocardiography: 2D imaging, color Doppler and pulse wave velocity measurements of inflow and outflow through the cardiac valves. Tissue Doppler imaging as well as speckle tracking strain of wall movement. Hepatic venous blood flow patterns and superior caval venous (Glenn) flow patterns. - Cardiopulmonary Exercise Stress Testing: Maximal oxygen consumption, VE/VCO2 relationship and the measurement of the Oxygen Uptake Efficiency Slope (OUES). - Blood Sampling: Electrolytes (Na and K), kidney function (Creatinin and Urea), liver function (ASAT, ALAT, alkalic fosfatase, gamma globulin and bilirubin levels), albumin and NT-pro BNP levels. - 24-hour monitoring of electrocardiography and impedance cardiography: heart rate, heart rate variability, stroke volume, pre ejection period and respiratory sinus arrhythmia. - Aortic	—

Measure

Time frame

Main Objective: -To treat Fontan patients for 3 months with the ACE inhibitor enalapril and compare a set of cardiovascular measurements before and after treatment in order to study its effect on the cardiovascular system in Fontan patients. ;Secondary Objective: -To assess autonomic parasympathetic and sympathetic function as well as vascular function in a population of patients with univentricular hearts palliated by the Fontan procedure and compare it with the results in healthy subjects. -To assess the effects of central fluid depletion by means of a passive head-up-tilt test and central fluid loading by passive leg raising on cardiac output, aortic distensibility and hepatic venous blood flow patterns in a group of patients with a Fontan circulation and compare it with the results in healthy controls. -To correlate the above mentioned results with the results of a symptom limited maximal exercise test. -To study the effect of a reversible fluid challenge and fluid depletion on cardiovascular parameters before and after a period of enalapril treatment in order to study changes in fluid susceptibility in Fontan patients. ;Primary end point(s): - Echocardiography: 2D imaging, color Doppler and pulse wave velocity measurements of inflow and outflow through the cardiac valves. Tissue Doppler imaging as well as speckle tracking strain of wall movement. Hepatic venous blood flow patterns and superior caval venous (Glenn) flow patterns. - Cardiopulmonary Exercise Stress Testing: Maximal oxygen consumption, VE/VCO2 relationship and the measurement of the Oxygen Uptake Efficiency Slope (OUES). - Blood Sampling: Electrolytes (Na and K), kidney function (Creatinin and Urea), liver function (ASAT, ALAT, alkalic fosfatase, gamma globulin and bilirubin levels), albumin and NT-pro BNP levels. - 24-hour monitoring of electrocardiography and impedance cardiography: heart rate, heart rate variability, stroke volume, pre ejection period and respiratory sinus arrhythmia. - Aortic

—

Secondary

Measure	Time frame
Secondary end point(s): There ar no secondary end points;Timepoint(s) of evaluation of this end point: There ar no secondary end points	—

Countries

Netherlands

Contacts

Public ContactDr. A.D.J. ten Harkel

Leids Universitair Medisch Centrum

A.D.J.ten_Harkel@lumc.nl00310715262833

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026