To study the feasibility of invasive exercise right heart catheterization in adult patients with repaired tetralogy of Fallot and severe PR and to study exercise parameters in volume loaded RV in repaired tetralogy of Fallot which could help to…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in cardiac index at peak exercise between patients with an
indication for PVR versus patients without an indication.
Secondary outcome
1. The safety of invasive exercise right heart catheterization in this specific
population by quantifying the amount of procedure-related (serious) adverse
events.
2. Difference between PCWP, mean RAP and RAP/PCWP ratio at peak exercise
between patients with and without an indication for PVR.
3. PCWP at peak exercise; cardiac index at peak exercise; mean pulmonary artery
pressure at peak exercise; mean RAP at peak exercise; RAP/PCWP ratio at peak
exercise; PCWP minus RAP at peak exercise; RV stroke work index at peak
exercise.
4. All these individual parameters at rest and at 20 Watt exercise.
5. Change in all the individual parameters objective from rest to peak exercise.
6. Peak work load achieved in Watts.
Background summary
Many adult patients with a repaired tetralogy of Fallot have severe, residual
pulmonary regurgitation (PR) requiring a pulmonary valve replacement (PVR)
later in life. PVR is recommended in patients with symptoms that are
unequivocally due to severe PR. In asymptomatic patients however, PVR should
also be considered when severe PR is seen in combination with e.g. a decrease
in objective exercise capacity, progressive right ventricular (RV) dilatation,
progressive tricuspid regurgitation, progressive RV systolic dysfunction,
and/or a wide QRS duration on electrocardiography. However, the optimal timing
of PVR in this specific group of patients with severe, residual PR remains
challenging, especially in asymptomatic patients. This clinical dilemma has
also been acknowledged in the most recent Guidelines on Adult Congenital Heart
Disease as an important gap in evidence. Except for cardiopulmonary exercise
testing (CPET), most parameters that guide the decision on timing of PVR are
obtained at resting conditions. Yet, patients typically complain of symptoms
during exercise and very often a dissociation is seen between reported symptoms
and only minor functional and/or morphological abnormalities on resting cardiac
imaging. We hypothesize that invasive hemodynamic exercise testing may unmask
important hemodynamic abnormalities caused by severe PR and RV volume overload.
Hemodynamic perturbations revealed with exercise may help in the understanding
of the consequences of severe, longstanding PR and may guide further studies
that aim to optimize the timing of PVR, especially in the difficult group of
*asymptomatic* patients.
Study objective
To study the feasibility of invasive exercise right heart catheterization in
adult patients with repaired tetralogy of Fallot and severe PR and to study
exercise parameters in volume loaded RV in repaired tetralogy of Fallot which
could help to improve the timing of PVR.
Study design
Feasibility/pilot study.
Study burden and risks
Right heart catheterization in an experienced centre is associated with a low
risk of minor and major complications. The risk of complications related to
venous access (e.g. hematoma, vagal reactions and pneumothoraxes) was, all
together, <1.0%. The risk of complications directly related to right heart
catheterization (e.g. arrhythmia, hypotensive episodes, transient ischemic
attack) was, all together, 0.003%. The risk of mortality was 0.055%). Patients
need to be hospitalized at the day of the procedure and need to undergo an
invasive right heart catheterization requiring venous access via the internal
jugular vein while performing a bicycle exercise test in supine position, which
will take approximately 30-60 minutes whereby the patient will be in the HC
room for a totalduration of approximately 1-2 hours.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Age 18 years or older
2. Repaired tetralogy of Fallot with or without a transannular patch.
3. Severe PR.
4. Ability to perform a supine bicycle exercise test.
5. Willingness to sign informed consent
Exclusion criteria
1. More than moderate tricuspid regurgitation.
2. Significant residual shunt (e.g. residual aorto-pulmonary shunt, ventricular
septal defect or arteriovenous shunts).
3. Moderate or severe RV outflow tract obstruction or known pulmonary artery
stenosis.
4. Inability to perform a supine bicycle exercise test.
5. Pregnancy. Women of childbearing age must provide a negative pregnancy test.
6. Mechanical valvular prosthesis in the pulmonary or tricuspid valve position.
7. Pulmonary embolism.
8. Pulmonary arterial hypertension with pulmonary vascular resistance >=3 Wood
units
9. Uncontrolled arrhythmia with resting heart rate >110 bpm.
10. Decompensated heart failure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87508.042.24 |