Status:
COMPLETED
Renal Arterial Denervation in Sympathetic Dysautonomia
Lead Sponsor:
St Carlos Hospital, Madrid, Spain
Conditions:
Hypertension
Renal Denervation
Eligibility:
All Genders
18+ years
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 evaluati...
Eligibility Criteria
Inclusion
- All patients included in a prospective manner must sign an informed written consent and meet ALL of the following criteria that are typical of the procedure according to the protocol of our center:
- Be considered adequate and eligible by the group of doctors responsible for the patient and by the multidisciplinary team of the study. Over 18 years, not pregnant.
- Poorly controlled arterial hypertension, under treatment with at least one antihypertensive drug.
- In addition, poorly controlled hypertension + increased variability, considering as such a standard deviation\> 10 mmHg for systolic BP and\> 5 for the diastolic BP of patient´s blood pressure levels, measured by ABPM.
- Renal arteries anatomy suitable for the procedure, considered by CT, MRI, ultrasound or angiography.
- Some criteria of dysautonomia, following the consensus of the American Autonomous Society (AAS) and the European Federation of Autonomous Societies (EFAS) of 2018.
- or supine HTN. Defined as sBP ≥ 140 mmHg and / or dBP ≥ 90 mmHg, measured at least after 5 minutes of supine rest. Moderate forms (160-179 mmHg or dBP of 100-109 mmHg) or severe will preferably be included. (sBP≥ 180 mmHg and / or dBP ≥ 110 mmHg). Mild forms will be considered in conjunction with symptoms or other findings (ABPM) or nighttime HTN. Considered as such one that does not fall more than 10% compared to the daytime BP or even rises (riser). They will be considered in conjunction with symptoms or other findings (eg ABMP).
- If the foregoing is not fulfilled, marked orthostatism (\> 30 mmHG in sBP and / or\> 10mmHG in dBP).
- Life expectancy exceeding one year (not presenting terminal illness or any health condition for which a survival of less than one year is estimated).
Exclusion
- eGFR \<30 mL / min / 1.73m2.
- Monoxidin treatment.
- Impossibility of informed consent by the patient or legal representative.
- Impossibility for follow-up at least 1 year.
- Do not fulfill inclusion criteria, assessed by the multidisciplinary team.
Key Trial Info
Start Date :
March 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04314557
Start Date
March 14 2019
End Date
May 31 2025
Last Update
July 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínico San Carlos
Madrid, Spain, 28040