Tetralogy of FallotFallotNCT03835494
Analysis of RV-Dysfunction in Fallot Patients
A study testing Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings. in people with Tetralogy of Fallot, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with corrected tetralogy of Fallot
- Adult healthy controls without cardiovascular disease or other relevant systemic diseases with written consent
Who cannot join
- Inability to give written consent, incapable of cycling or handgrip exercise due to cognitive or orthopedic limitation, poor echocardiographic image quality
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult 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.
Read the 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.
- Conditions
- Tetralogy of Fallot
- Being tested
- Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
- Keywords
- Tetralogy of Fallot, Tissue Doppler Imaging, Exercise testing
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fallot patients | Experimental | Fallot patients Receives: 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 | Experimental | healthy volunteers Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835494
- Sponsor's protocol ID
- Fallot
- Acronym
- Fallot
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients
- ClinicalTrials.gov ID
- NCT03835494
- Acronym / sponsor ID
- Fallot / Fallot
- Conditions
- Tetralogy of Fallot
- Keywords
- Tetralogy of Fallot, Tissue Doppler Imaging, Exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Fallot patients | Experimental | 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.Fallot patients |
| healthy controls | Experimental | 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 volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with corrected tetralogy of Fallot
- Adult healthy controls without cardiovascular disease or other relevant systemic diseases with written consent
Key exclusion criteria (1 listed)
- Inability to give written consent, incapable of cycling or handgrip exercise due to cognitive or orthopedic limitation, poor echocardiographic image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.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 | Fallot patients, healthy controls |
Primary outcome
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)
1 secondary outcome
Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings. in people with Tetralogy of Fallot, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular myocardial velocity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.