Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot

Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot - The leg-positive pressure echocardiography for patients with repaired tetralogy of Fallot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038369

Enrollment

Registered

2019-10-24

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Tetralogy of Fallot

Interventions

at rest and stress using the leg-positive pressure maneuver

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: repaired tetralogy of Fallot

Exclusion criteria

Exclusion criteria: (1) RV end-diastolic volume index exceeds 170 mL/m2 and/or RV end-systolic volume index exceeds 85 mL/m2 with severe PR (2) open-heart surgery within 6 months; (3) unstable heart failure; (4) unable to undergo LPP stress; (5) arrhythmia such as atrial fibrillation, second degree and third degree atrioventricular block and VVI pacing after pacemaker implantation; (6) orthopedic traumatic disease or active skin lesions in the lower limbs.

Design outcomes

Primary

Measure	Time frame
RV function and forward stroke volume at baseline and during LPP stress.	—

Secondary

Measure	Time frame
Standerd functional assessment, ventricular interaction between RV and left ventricle,left ventriclar diastolic dysfunction and BNP at baseline and during LPP stress.	—

Countries

Japan

Contacts

Public ContactKensuke Matsumoto

Kobe University Hospital Division of Cardiovascular Medicine, Department of Internal Medicine

kenmatsu@med.kobe-u.ac.jp0783825846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026