To study the clinical value of pressure and flow assessment for predicting treatment response to PTRA and validate the pressure gradient assessment by CFD in patients with available CT angiography.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Receiver operating characteristics for predicting ambulatory blood pressure
response after renal angioplasty by (1) the hyperemic pressure gradient, (2)
the hyperemic pressure gradient and the renal flow reserve.
Secondary outcome
The level of agreement between the CFD-predicted hyperemic pressure drop and
the invasively measured pressure drop.
Background summary
In patients with renal artery stenosis (RAS), pressure and flow measurements in
the renal artery may help identify patients who will benefit from percutaneous
transluminal renal angioplasty (PTRA). Based on the findings of the first HERA
study and the ongoing HERA-2 study, pressure and flow measurements under
dopamine infusion in the renal artery are feasible, safe and reproducible.
Moreover, image-based computational fluid dynamics (CFD) using CT angiography
may be able to non-invasively reproduce these pressure measurements, which can
strongly increase the clinical applicability of functional assessment in this
disease. CFD simulations have recently been validated and approved for deciding
in which patients to perform a percutaneous coronary intervention. To date, no
clinical validation of CFD simulations in the renal artery is available.
Study objective
To study the clinical value of pressure and flow assessment for predicting
treatment response to PTRA and validate the pressure gradient assessment by CFD
in patients with available CT angiography.
Study design
Single-center, cohort study with invasive measurements.
Study burden and risks
The burden of this study consists of exposure to an additional 8 ml of contrast
medium for guide wire positioning, along with an intra-renal bolus of 30 µg/kg
dopamine. The duration of the catheterization procedure is lengthened by an
additional 30 minutes, and the study incus two extra hospital visits of 7,5
hours for renal clearance measurements. A total of 146 ml of blood is collected
during renal clearance measuements. The intra-renal measurements and additional
kidney clearance measurement incur a radiation burden of at most 4.8 mSv.
Patients have no direct individual benefit by participating in the study, but
their participation does contribute to a potentially improved treatment
selection for future patients with the same disease.
Meibergdreef 9
Amsterdam 115AZ
NL
Meibergdreef 9
Amsterdam 115AZ
NL
Listed location countries
Age
Inclusion criteria
Age > 18
Written informed consent
Clinical indication for percutaneous transluminal renal angioplasty
Clinically and hemodynamically stable
CT-angiogram or MR-angiogram of the renal arteries
Renography
Exclusion criteria
Known atrial fibrillation with irregular ventricular response rate
Increased risk for contrast nephropathy defined as presence of renal impairment
(eGFR <30ml/min) according to the Guideline Safe Use of Contrast Media of the
Radiology Society of the Netherlands (November 2017)
Women of child bearing age not on active birth control
Inability to sign an informed consent, due to any mental condition that renders
the
subject unable to understand the nature, scope, and possible consequences of
the trial or due to mental retardation or language barrier
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 | NL71172.018.19 |