Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT03835494
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of RV-Dysfunction in Fallot Patients
Sponsor:
Klinik für Kardiologie, Pneumologie und Angiologie
Organization:
Study Overview
Official Title:
Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fallot
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: