The primary objective of this study is to assess the dynamic range of renal pressure and flow velocity under exercise induced minimal flow and dopamine induced hyperemia. Secondary objectives are to assess intra-individual variations in the range of…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dynamic range of renal blood flow, represented by the relative baseline flow,
the ratio between the difference of baseline and minimal flow velocity and
baseline flow velocity.
Secondary outcome
Renal flow reserve, relative minimal flow, renal fractional flow reserve,
baseline and hyperemic renal stenosis resistance, baseline and hyperemic
microvascular resistance, phase difference between pressure and flow in
sympathetic band for autoregulation.
In patients where offline renal perfusion analysis is possible: renal perfusion
as area under the curve of contrast density over time and the renal flow
reserve computed by perfusion angiography.
Correlation of main study parameters with relevant clinical, biochemical and
imaging parameters.
Background summary
In patients with atherosclerotic renal artery stenosis (RAS), combined
intra-renal pressure and flow measurements allow a comprehensive evaluation of
macro- and microvascular renal disease, which may help to identify patients who
will benefit from percutaneous transluminal renal angioplasty (PTRA). Based on
the findings of the first HERA study, intra-renal pressure and flow
measurements are feasible, safe and reproducible. Before we study the clinical
utility of pressure-and flow guided renal revascularization, we first need to
determine the physiological range of pressure and flow variations in the renal
artery. This can be performed by measuring exercise-induced minimal flow next
to dopamine-induced hyperemia. In addition, the relation of pressure and flow
may also help us to assess renal autoregulation which is important for the
maintenance of renal perfusion in patients with renovascular disease and
chronic kidney insufficiency.
Study objective
The primary objective of this study is to assess the dynamic range of renal
pressure and flow velocity under exercise induced minimal flow and dopamine
induced hyperemia. Secondary objectives are to assess intra-individual
variations in the range of pressure and flow and to assess renal
autoregulation.
Study design
Single-center, cohort study with invasive measurements.
Study burden and risks
The burden of this study consists of exposure to an additional 30 ml of
contrast medium for renal angiography and the placement of a 0.014-inch guide
wire with pressure and flow sensors (Combowire, Philips-Volcano, San Diego, US)
in one of the renal arteries. In addition, a renal hyperaemic response is
induced by an intra-renal bolus of 30 *g·kg-1 dopamine. The duration of the
catheterization procedure is lengthened by an additional 30 minutes. A total of
50 ml of blood is collected during catheterization. The risks of this study
consist of the occurrence of contrast nephropathy, renal artery dissection and
cholesterol embolization. These risks are considered very small as no
catheter-based intervention takes place in the renal arteries. In the first
HERA study that used a more extensive protocol with duplicate measurements to
assess reproducibility, no adverse events occurred in the 39 patients who
participated in that study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Age > 18
Written informed consent
Clinically and hemodynamically stable
Clinical indication for a coronary, renal, or peripheral vascular angiography
with or without percutaneous intervention.
Exclusion criteria
Recent ST-segment elevation myocardial infarction (<6 weeks prior to enrolment)
Known cardiac arrhythmias
Known heart failure (NYHA class > II)
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 | NL68272.018.18 |