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OpenTrials
Completed

NCT Number: NCT03835494

Analysis of RV-Dysfunction in Fallot Patients

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 outcomes

  1. Right ventricular myocardial velocity

    Time frame: 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 outcomes

  1. Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients

Acronym: Fallot

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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