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HypertensionRANSOMNCT04314557

Renal Arterial Denervation in Sympathetic Dysautonomia

An observational study of Hypertension and Renal Denervation, run by St Carlos Hospital, Madrid, Spain at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Renal denervation
Type of treatment
Medical device
How many people
13 participants
Where
1 siteSpain
Study dates
14 Mar 2019to 31 May 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: All comers.

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínico San Carlos

    Madrid, 28040

Other trials in Spain

About this study

Official title: Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY

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.

Being tested
Renal denervation
Keywords
Sympathetic dysautonomia, Blood Pressure Variability, Hypertension, Renal denervation
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal denervationDevice

    Spyral device. Bilateral renal denervation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the descent of Systolic BP in orthostatism

    BP Variability decrease, any (yes/no).

    Measured: 12 months

Secondary outcomes (4)

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

    BP Variability decrease < 25 percent (yes/no)

    Measured: 12 months

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

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

    Measured: 12 months

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

    AMPA measure mean PA levels (numeric)

    Measured: 12 months

  4. Safety end points

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start14 Mar 2019
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
13 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314557
Sponsor's protocol ID
18/532-O_P
Acronym
RANSOM
Status last verified
Jul 2025
First submitted
16 Dec 2019
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Catala-Lopez F, Sanfelix-Gimeno G, Garcia-Torres C, Ridao M, Peiro S. Control of arterial hypertension in Spain: a systematic review and meta-analysis of 76 epidemiological studies on 341 632 participants. J Hypertens. 2012 Jan;30(1):168-76. doi: 10.1097/HJH.0b013e32834d30ec.

    PubMed 22025240

  • Kotseva K, De Bacquer D, De Backer G, Ryden L, Jennings C, Gyberg V, Abreu A, Aguiar C, Conde AC, Davletov K, Dilic M, Dolzhenko M, Gaita D, Georgiev B, Gotcheva N, Lalic N, Laucevicius A, Lovic D, Mancas S, Milicic D, Oganov R, Pajak A, Pogosova N, Reiner Z, Vulic D, Wood D, On Behalf Of The Euroaspire Investigators. Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. Eur J Prev Cardiol. 2016 Dec;23(18):2007-2018. doi: 10.1177/2047487316667784. Epub 2016 Sep 27.

    PubMed 27638542

  • Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

    PubMed 30165516

  • Hering D, Grassi G. Effects of renal denervation on short-term blood pressure variability: lack of meta-analytic evidence. J Hypertens. 2017 Sep;35(9):1780-1781. doi: 10.1097/HJH.0000000000001397. No abstract available.

    PubMed 28767486

  • Fanciulli A, Jordan J, Biaggioni I, Calandra-Buonaura G, Cheshire WP, Cortelli P, Eschlboeck S, Grassi G, Hilz MJ, Kaufmann H, Lahrmann H, Mancia G, Mayer G, Norcliffe-Kaufmann L, Pavy-Le Traon A, Raj SR, Robertson D, Rocha I, Struhal W, Thijs R, Tsioufis KP, van Dijk JG, Wenning GK. Consensus statement on the definition of neurogenic supine hypertension in cardiovascular autonomic failure by the American Autonomic Society (AAS) and the European Federation of Autonomic Societies (EFAS) : Endorsed by the European Academy of Neurology (EAN) and the European Society of Hypertension (ESH). Clin Auton Res. 2018 Aug;28(4):355-362. doi: 10.1007/s10286-018-0529-8. Epub 2018 May 15.

    PubMed 29766366

  • Núñez-Gil IJ. Protocolo Asistencial de denervación renal percutánea mediante radiofrecuencia. Hospital Clínico San Carlos 2016.

  • Nunez-Gil IJ, Garcia-Donaire JA, Vedia O, Abad-Cardiel M, Martell-Claros N, Fernandez-Ortiz A. [Initial experience with a multi-electrode catheter in renal denervation. A technique that has come back to stay?]. Hipertens Riesgo Vasc. 2019 Jul-Sep;36(3):166-168. doi: 10.1016/j.hipert.2019.04.002. Epub 2019 May 31. No abstract available. Spanish.

    PubMed 31160234

  • Travieso-Gonzalez A, Nunez-Gil IJ, Riha H, Donaire JAG, Ramakrishna H. Management of Arterial Hypertension: 2018 ACC/AHA Versus ESC Guidelines and Perioperative Implications. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3496-3503. doi: 10.1053/j.jvca.2019.03.068. Epub 2019 Apr 3.

    PubMed 31078374

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Renal Denervation, run by St Carlos Hospital, Madrid, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the descent of Systolic BP in orthostatism (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04314557, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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