Renal Arterial Denervation in Sympathetic Dysautonomia

Launched by ST CARLOS HOSPITAL, MADRID, SPAIN · Mar 17, 2020

Keywords

ClinConnect Summary

The RANSOM registry is a clinical trial that aims to study the effects of a procedure called renal sympathetic denervation on patients with high blood pressure (hypertension) and specific problems related to blood pressure variability. This procedure is designed for patients who are already taking at least one medication for high blood pressure but still have poorly controlled blood pressure that fluctuates a lot. The goal is to see how this treatment may improve their blood pressure, quality of life, and levels of certain hormones called catecholamines, while also examining its safety.

To be eligible for this trial, participants must be adults over 18 years old who have high blood pressure that isn't well controlled despite treatment. They should also have significant fluctuations in their blood pressure measurements. Patients with certain kidney conditions or who are unable to give consent will not be included. Those who join the study can expect to be closely monitored for about a year to assess how well the treatment works for them. The trial is currently recruiting participants and aims to provide valuable information that can help improve treatment for people with hypertension and related issues.

Gender

ALL

Eligibility criteria

• 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.