Renal Arterial Denervation in Sympathetic Dysautonomia (RANSOM)

St Carlos Hospital, Madrid, Spain

Status: Completed

Conditions: Blood Pressure Disorders; Hypertension; Increased Variability; Renal Denervation; Blood Pressure Variability; Sympathetic Dysautonomia

Treatments: Device: Renal denervation

Study type: Observational

Funder types: Other

Identifiers

NCT04314557

18/532-O_P

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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> 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 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.