Fontan patients: Evaluation of the pulmonary circulation to identify pulmonary vascular disease and its influence on ventricular function.

Fontan patients: Comprehensive evaluation of the pulmonary circulation to identify pulmonary vascular disease and its influence on ventricular hemodynamics. - Fontan patients: pulmonary circulation and ventricular hemodynamics.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001784-77-BE

Enrollment

Registered

2012-04-12

Start date

2012-05-07

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Fontan patients MedDRA version: 14.1 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Viagra 50 mg Product Name: Sildenafil citrate 50 mg Product Code: G04B Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - = 14 years of age - Written informed consent - Fontan pathology Are the trial subjects under 18? yes Number of subjects for this age range: 7 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Inability to performe exercise - Contra-indication for MR evaluation

Design outcomes

Primary

Measure	Time frame
Main Objective: - Effect of Sildenafil 50 mg on PVR, ventricular volume and function at rest ;Secondary Objective: - Feasibility of measuring PVR in Fontan patients using simultaneous acquisition of invasive pressures and MR flow data. - Effect of bicycle stress on PVR, ventricular volume and function - Evaluating the reliability of bicycle stress echocardiography in determining ventricular volume and function as an indirect parameter reflecting the status of the pulmonary vasculature;Primary end point(s): Stroke volume during exercise;Timepoint(s) of evaluation of this end point: 30 minutes after administration of Sildenafil citrate 50 mg	—

Measure

Time frame

Main Objective: - Effect of Sildenafil 50 mg on PVR, ventricular volume and function at rest ;Secondary Objective: - Feasibility of measuring PVR in Fontan patients using simultaneous acquisition of invasive pressures and MR flow data. - Effect of bicycle stress on PVR, ventricular volume and function - Evaluating the reliability of bicycle stress echocardiography in determining ventricular volume and function as an indirect parameter reflecting the status of the pulmonary vasculature;Primary end point(s): Stroke volume during exercise;Timepoint(s) of evaluation of this end point: 30 minutes after administration of Sildenafil citrate 50 mg

—

Secondary

Measure	Time frame
Secondary end point(s): Pulmonary vascular resistance;Timepoint(s) of evaluation of this end point: 30 minutes after administration of Sildenafil citrate 50 mg	—

Countries

Belgium

Contacts

Public ContactDepartment of Cardiology

University Hospitals Leuven

sonia.rens@uzleuven.be+3216344369

Outcome results

None listed

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