To investigate whether pRDN leads to a change in renal blood flow
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primarily the effect of pRDN on renal blood flow, assessed by a change in
average peak flow velocity, both in baseline as well as hyperaemic conditions.
Secondary outcome
The effect of pRDN on renal flow reserve (RFR), and hyperaemic microvascular
resistance (HMR).
Background summary
Although many studies have studied the effect and safety of pRDN, it remains
unknown what the exact mechanism behind renal denervation is. Small animal
studies have suggested an improvement of flow after pRDN in pigs experiments
(presented at ACC 2012). It can be hypothesized that a difference in renal
blood flow leads to an improved renal perfusion, and consequently a reduced BP.
In the light of this ignorance, we wish to perform an observational study to
investigate whether pRDN leads to a difference in renal blood flow after
treatment with pRDN.
Study objective
To investigate whether pRDN leads to a change in renal blood flow
Study design
Monocentre, observational pilot study in 20 patients.
Study burden and risks
The risks associated with the measurements described are acceptable. Based on
clinical experience, we do not expect any potential risks regarding this trial.
Possible complications include a slightly increased infection risk due to
prolonged duration of the denervation.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Individual is accepted for treatment with renal denervation as standard therapy for resistant hypertension.
2. Individual is >=18 years of age.
3.Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.
Exclusion criteria
1.Individual is excluded from treatment with pRDN .
2.Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
3.Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
4.Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
5.Individual is pregnant, nursing or planning to be pregnant.
6.Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
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 | NL42766.041.12 |