Analysis of RV-Dysfunction in Fallot Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tetralogy of Fallot

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Transthoracic echocardiography including TDI is performed at rest, during PLR, HG and CPX in Fallot patients and healthy controls. In Fallot patients, transthoracic ultrasound at rest and during CPX are part of the routinely follow-up. PLR and HG were performed additionally as part of the investigator's study to analyze TDI parameters during various endurance testings

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fallot patients

Group Type EXPERIMENTAL

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

Intervention Type 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.

healthy controls

healthy volunteers

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes