RANSOM: Renal Arterial Denervation in Sympathetic Dysautonomia

Sponsor
St Carlos Hospital, Madrid, Spain (Other)
Overall Status
Recruiting
CT.gov ID
NCT04314557
Collaborator
(none)
20
1
45.6
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Renal denervation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY
Actual Study Start Date :
Mar 14, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Change in the descent of Systolic BP in orthostatism [12 months]

    BP Variability decrease, any (yes/no).

Secondary Outcome Measures

  1. Change in the descent of Systolic BP in orthostatism. [12 months]

    BP Variability decrease < 25 percent (yes/no)

  2. Measurement of quality of life and subjective perception of well-being. [12 months]

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

  3. Evolution of blood pressure control, average levels and variability [12 months]

    AMPA measure mean PA levels (numeric)

  4. Safety end points [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clínico San Carlos Madrid Spain 28040

Sponsors and Collaborators

  • St Carlos Hospital, Madrid, Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
IVAN J NUÑEZ GIL, Principal Investigator. Attending Physician. MD, PhD, FESC, St Carlos Hospital, Madrid, Spain
ClinicalTrials.gov Identifier:
NCT04314557
Other Study ID Numbers:
  • 18/532-O_P
First Posted:
Mar 19, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by IVAN J NUÑEZ GIL, Principal Investigator. Attending Physician. MD, PhD, FESC, St Carlos Hospital, Madrid, Spain
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022