Analysis of RV-Dysfunction in Fallot Patients (Fallot)
Primary Purpose
Tetralogy of Fallot
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
Sponsored by
About this trial
This is an interventional other trial for Tetralogy of Fallot focused on measuring Tetralogy of Fallot, Tissue Doppler Imaging, Exercise testing
Eligibility 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
Sites / Locations
- Division of Cardiology, Pulmonary Disease and Vascular Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fallot patients
healthy controls
Arm Description
Fallot patients
healthy volunteers
Outcomes
Primary Outcome Measures
Right ventricular myocardial velocity
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
Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)
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
Full Information
NCT ID
NCT03835494
First Posted
January 8, 2019
Last Updated
March 11, 2019
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
1. Study Identification
Unique Protocol Identification Number
NCT03835494
Brief Title
Analysis of RV-Dysfunction in Fallot Patients
Acronym
Fallot
Official Title
Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot
Keywords
Tetralogy of Fallot, Tissue Doppler Imaging, Exercise testing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fallot patients
Arm Type
Experimental
Arm Description
Fallot patients
Arm Title
healthy controls
Arm Type
Experimental
Arm Description
healthy volunteers
Intervention Type
Other
Intervention Name(s)
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 Description
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 Measure Information:
Title
Right ventricular myocardial velocity
Description
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)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)
Description
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
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Division of Cardiology, Pulmonary Disease and Vascular Medicine
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Analysis of RV-Dysfunction in Fallot Patients
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