Analysis of RV-Dysfunction in Fallot Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03835494
• Date of registration: 08/01/2019
• Prospective Registration: No
• Primary sponsor: Klinik für Kardiologie, Pneumologie und Angiologie
• Public title: Analysis of RV-Dysfunction in Fallot Patients Fallot
• Scientific title: Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients
• Date of first enrolment: November 1, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03835494
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with corrected tetralogy of Fallot

- Adult healthy controls without cardiovascular disease or other relevant systemic
diseases with written consent

Exclusion Criteria:

- Inability to give written consent, incapable of cycling or handgrip exercise due to
cognitive or orthopedic limitation, poor echocardiographic image quality



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tetralogy of Fallot

Intervention(s)

Other: Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.

Primary Outcome(s)

Right ventricular myocardial velocity [Time Frame: Baseline]

Secondary Outcome(s)

Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg) [Time Frame: Baseline]

Secondary ID(s)

Fallot

Source(s) of Monetary Support

Please refer to primary and secondary sponsors