ACE inhibition in Fontan patients: its effect on body fluid regulation.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46953

Enrollment

110

Registered

2017-02-22

Start date

2017-06-12

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Fontan circulation

Interventions

To all Fontan patients enalapril will be given twice daily at a dose of 0,5 mg/kg/day with a maximum of 20 mg per day. Enalapril will be titrated on average in two steps, by blood pressure measureme

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Fontan patiënts Patiënts from 8 until 18 years old

Exclusion criteria

Exclusion criteria: Fontan patients who already use enalapril

Design outcomes

Primary

Measure	Time frame
- Cardiopulmonary exercise stress test: VO2peak (maximal oxygen consumption) - Cardiac autonomic nervous activity: heart rate variability and pre-ejection period. - Outcome of passive leg raising and head up tilt table testing: cardiac output and cardiac autonomic tone.	—

Secondary

Measure	Time frame
- 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: 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, stroke volume and respiratory sinus arrhythmia. - Aortic stiffness: pulse wave velocity of the aorta, augmentation index and central blood pressure - Outcome of passive leg raising: aortic pulse wave velocity and hepatic venous blood flow, saturation, End Tidal CO2, cerebral blood flow and continuous blood pressure measurement. - Outcome of head up tilt table testing: aortic pulse wave velocity, cardiac output and hepatic venous blood flow, saturation, End Tidal CO2, cerebral blood flow and continuous blood pressure measurement.	—

Measure

Time frame

- 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: 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, stroke volume and respiratory sinus arrhythmia. - Aortic stiffness: pulse wave velocity of the aorta, augmentation index and central blood pressure - Outcome of passive leg raising: aortic pulse wave velocity and hepatic venous blood flow, saturation, End Tidal CO2, cerebral blood flow and continuous blood pressure measurement. - Outcome of head up tilt table testing: aortic pulse wave velocity, cardiac output and hepatic venous blood flow, saturation, End Tidal CO2, cerebral blood flow and continuous blood pressure measurement.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)