Analysis of RV-Dysfunction in Fallot Patients

Not Applicable

Completed

• Conditions: Tetralogy of Fallot
• Interventions: 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.

• Registration Number: NCT03835494
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Brief Summary

In the presented study TDI will be used as a modern technique to characterize RV-function in Fallot patients at rest and during different exercise conditions.

Detailed Description

Tissue Doppler imaging (TDI) presents a modern technique to depict the velocity of tissue motion within a distinct area of the myocardium providing amendatory characterization of diastolic and systolic function of the heart. TDI is hypothesized to be of additional value in the evaluation of adult congenital heart disease, especially tetralogy of Fallot (TOF), which is one of the most common conditions. In particular, Fallot patients are at risk of developing right ventricular (RV) dysfunction due to pulmonary valve defects or alterations of the outflow tract. It is pivotal to recognize this progression at an early stage before irreversible changes occur. Aim of the study is to test feasibility of TDI in Fallot patients as a new technique that provides new parameters to characterize RV dysfunction, more precise than common methods. Additionally TDI is performed at rest and during different endurance testings (passive Leg Raising (PLR), handgrip (HG) and cardiopulmonary exercise (CPX), as certain changes might be compensated at rest, first apparent during exercise.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fallot patients	Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.	Fallot patients
healthy controls	Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.	healthy volunteers

Primary Outcome Measures

Name	Time	Method
Right ventricular myocardial velocity	Baseline	Right ventricular myocardial velocity during early diastole (cm/s) Right ventricular myocardial velocity during late diastole (cm/s) Right ventricular myocardial velocity during systole (cm/s) baseline (one time point, measurements are performed at rest and during exercise)

Secondary Outcome Measures

Name	Time	Method
Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)	Baseline	CPX is performed for the measurement of TDI velocities at peak exercise, as well as for the assessment of the participants´ cardiopulmonary status. For the latter, the focus lies on oxygen consumption at peak exercise and at anaerobic threshold

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany