Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT04314557
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Arterial Denervation in Sympathetic Dysautonomia
Sponsor:
St Carlos Hospital, Madrid, Spain
Organization:
Study Overview
Official Title:
Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RANSOM
Brief Summary:
The RANSOM registry is considered as a collection of data with the ultimate purpose of gathering information about the effect of renal denervation in patients of the investigator's center and evaluating the results within the usual clinical practice.
The general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation\> 10 mmHg for systolic BP and\> 5 for diastolic BP of its blood pressure levels, measured by ABPM.
The general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation\> 10 mmHg for systolic BP and\> 5 for diastolic BP of its blood pressure levels, measured by ABPM.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: