Skip to main content
OpenTrials
Completed

NCT Number: NCT04314557

Renal Arterial Denervation in Sympathetic Dysautonomia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Renal Denervation

Device

Spyral device. Bilateral renal denervation.

Primary outcomes

  1. Change in the descent of Systolic BP in orthostatism

    Time frame: 12 months

    BP Variability decrease, any (yes/no).

Secondary outcomes

  1. Change in the descent of Systolic BP in orthostatism.

    Time frame: 12 months

    BP Variability decrease < 25 percent (yes/no)

  2. Measurement of quality of life and subjective perception of well-being.

    Time frame: 12 months

    Short form 12, questionaire (0-100, the higher the better).

  3. Evolution of blood pressure control, average levels and variability

    Time frame: 12 months

    AMPA measure mean PA levels (numeric)

  4. Safety end points

    Time frame: 12 months

    MACE (death,bleeding, renal failure-yes/no)

Sponsors and collaborators

Lead sponsor

St Carlos Hospital, Madrid, Spain

Other

Registry information

Official study title

Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY

Acronym: RANSOM

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2020
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.