Renal Arterial Denervation in Sympathetic Dysautonomia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    St Carlos Hospital, Madrid, Spain
Updated on 17 January 2022
angiography
hypertension
systolic blood pressure
antihypertensive drugs
blood pressure diastolic

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.

Details
Condition Hypertension, Renal Denervation, Increased Variability, Blood Pressure Disorders, Blood Pressure Variability, Sympathetic Dysautonomia
Treatment Renal denervation
Clinical Study IdentifierNCT04314557
SponsorSt Carlos Hospital, Madrid, Spain
Last Modified on17 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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>
mmHG 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 Criteria

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
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