Renal Hemodynamics in patients with a univentricular Fontan circulation

Renal Hemodynamics in patients with a univentricular Fontan circulation - Fontan-RH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53480

Enrollment

Registered

2023-10-18

Start date

2024-08-05

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Fontan circulation Univentricular circulations

Interventions

None listed

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: patients: 1. Patients on (intermittent or continuous) haemodialysis 2. Estimated glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results