Reassessing patients with repaired tetralogy of Fallot and severe pulmOnary Regurgitation using Cardiac Exercise hemodynamics

Reassessing patients with repaired tetralogy of Fallot and severe pulmOnary Regurgitation using Cardiac Exercise hemodynamics - R-FORCE I

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57416

Enrollment

Registered

2024-07-30

Start date

2025-10-17

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Pulmonary regurgitation Pulmonary valve leakage

Interventions

Exercise right heart catheterization

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Repaired tetralogy of Fallot with or without a transannular patch. 3. Severe PR. 4. Ability to perform a supine bicycle exercise test. 5. Willingness to sign informed consent

Exclusion criteria

Exclusion criteria: 1. More than moderate tricuspid regurgitation. 2. Significant residual shunt (e.g. residual aorto-pulmonary shunt, ventricular septal defect or arteriovenous shunts). 3. Moderate or severe RV outflow tract obstruction or known pulmonary artery stenosis. 4. Inability to perform a supine bicycle exercise test. 5. Pregnancy. Women of childbearing age must provide a negative pregnancy test. 6. Mechanical valvular prosthesis in the pulmonary or tricuspid valve position. 7. Pulmonary embolism. 8. Pulmonary arterial hypertension with pulmonary vascular resistance >=3 Wood units 9. Uncontrolled arrhythmia with resting heart rate >110 bpm. 10. Decompensated heart failure.

Design outcomes

Primary

Measure	Time frame
Difference in cardiac index at peak exercise between patients with an indication for PVR versus patients without an indication.	—

Secondary

Measure	Time frame
1. The safety of invasive exercise right heart catheterization in this specific population by quantifying the amount of procedure-related (serious) adverse events. 2. Difference between PCWP, mean RAP and RAP/PCWP ratio at peak exercise between patients with and without an indication for PVR. 3. PCWP at peak exercise; cardiac index at peak exercise; mean pulmonary artery pressure at peak exercise; mean RAP at peak exercise; RAP/PCWP ratio at peak exercise; PCWP minus RAP at peak exercise; RV stroke work index at peak exercise. 4. All these individual parameters at rest and at 20 Watt exercise. 5. Change in all the individual parameters objective from rest to peak exercise. 6. Peak work load achieved in Watts.	—

Measure

Time frame

1. The safety of invasive exercise right heart catheterization in this specific population by quantifying the amount of procedure-related (serious) adverse events. 2. Difference between PCWP, mean RAP and RAP/PCWP ratio at peak exercise between patients with and without an indication for PVR. 3. PCWP at peak exercise; cardiac index at peak exercise; mean pulmonary artery pressure at peak exercise; mean RAP at peak exercise; RAP/PCWP ratio at peak exercise; PCWP minus RAP at peak exercise; RV stroke work index at peak exercise. 4. All these individual parameters at rest and at 20 Watt exercise. 5. Change in all the individual parameters objective from rest to peak exercise. 6. Peak work load achieved in Watts.

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Countries

Netherlands

Contacts

Public ContactT.M. Gorter

Universitair Medisch Centrum Groningen

tm.gorter@umcg.nl0614025997

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 7, 2026