The primary objective is to determine whether iRVF patterns and renal damage/function are different in patients with a Fontan circulation compared to age and sex-matched healthy controls.The secondary objectives are to- Identify the prevalence of…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the difference in iRVF pattern measured via renal
sonography, renal function (eGFR) and renal damage (urine albumin, L-FABP and
cystatin C concentrations) between patients with a Fontan circulation vs.
healthy age and sex matched controls.
Secondary outcome
The secondary endpoints will include the following:
- Identify the prevalence of different iRVF patterns in patients with a Fontan
circulation assessed with renal ultrasound.
- Estimated glomerular filtration rate determined by serum creatinine and
plasma cystatin C.
- Concentration of urine albumin, L-FABP and cystatin C.
- Difference of eGFR between iRVF patterns.
- Difference in urine albumin, L-FABP and cystatin C concentration between
iRVF-patterns.
- Correlation of eGFR, urine albumin L-FABP and urine cystatin C to venous
discontinuity index (VDI) and/or venous impedance index (VII).
Background summary
Discontinuous intrarenal venous flow (iRVF) patterns are associated with poor
renal function and diuretic response in patients with biventricular circulation
who have elevated venous pressures. People with univentricular circulation, by
definition, have an elevated venous pressure. However, the role of iRVF
patterns on renal function in univentricular circulations has never been
established.
The hypothesis of this study is that, in patients with univentricular
circulation the iRVF patterns will be discontinuous compared to healthy
subjects and that the iRVF patterns will be associated with a decreased renal
function.
Study objective
The primary objective is to determine whether iRVF patterns and renal
damage/function are different in patients with a Fontan circulation compared to
age and sex-matched healthy controls.
The secondary objectives are to
- Identify the prevalence of different iRVF patterns in patients with a Fontan
circulation.
- Determine whether renal function as determined by estimated glomerular
filtration rate is different between iRVF patterns.
- Determine whether renal damage as assessed with glomerular and tubular damage
markers is different between iRVF patterns.
- Determine whether iRVF as defined by the venous discontinuity index (VDI) or
venous impedance index (VII) correlates to estimated glomerular filtration rate
in Fontan patients.
- Determine whether iRVF as defined by the venous discontinuity index (VDI) or
venous impedance index (VII) correlates to a degree of renal damage as assessed
with glomerular and tubular damage markers in Fontan patients.
Exploratory objectives include
- Whether the age of Fontan-patients is different between different
iRVF-patterns
- Whether the age of Fontan-patients is associated with either VDI or VII.
Study design
The proposed study is a single centre, cross-sectional observational
case-control study, including 40 patients with a univentricular circulation and
40 healthy controls.
Study burden and risks
Participating test subjects will be asked to pay a one-time visit to the
University Medical Center Groningen (UMCG).
For patients with a univentricular circulation, the study visit will, if
possible, take place during their annual visit to the UMCG's (pediatric)
cardiology outpatient clinic. For a brother or sister of a Fontan patient
participating in the healthy subject study, an appointment will be made to
schedule the same day as the patient.
Prior to the testing visit, patients will be asked to collect 24-hour urine
samples. During the testing visit, they will have to undergo a renal sonography
and a venapuncture. The risks associated with these procedures are very
limited, rare and include bleeding and infection for venipuncture and contact
dermatitis for the gel used during the sonography.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
patients:
1. Able and willing to give written informed consent
2. Male and female subjects with age >=12 years
3. Palliated with either of the four following *Fontan* circulations
a. Atrio-pulmonary connection
b. Lateral tunnel cavopulmonary connection (TCPC)
c. Extra-cardiac cavopulmonary connection (TCPC)
d. Kawashima circulation
controls:
1. Able and willing to give written informed consent
2. Male and female subjects with age >=12 years
Exclusion criteria
patients:
1. Patients on (intermittent or continuous) haemodialysis
2. Estimated glomerular filtration rate < 45 ml/min/1.73m2
3. Female patients pregnant at the time of inclusion and or study visit
controls:
1. Diagnosis of any cardiovascular disease in medical history
2. Diagnosis of any renal disease in medical history
3. Female subjects pregnant at the time of inclusion and or study visit
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82753.042.22 |