Blood Pressure Disorders, Blood Pressure Variability, Hypertension, Increased Variability, Renal Denervation, Sympathetic Dysautonomia
Conditions
Keywords
Sympathetic dysautonomia, Blood Pressure Variability, Hypertension, Renal denervation
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.
Interventions
DEVICERenal denervation
Spyral device. Bilateral renal denervation.
Sponsors
St Carlos Hospital, Madrid, Spain
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the descent of Systolic BP in orthostatism | 12 months | BP Variability decrease, any (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the descent of Systolic BP in orthostatism. | 12 months | BP Variability decrease \< 25 percent (yes/no) |
| Measurement of quality of life and subjective perception of well-being. | 12 months | Short form 12, questionaire (0-100, the higher the better). |
| Evolution of blood pressure control, average levels and variability | 12 months | AMPA measure mean PA levels (numeric) |
| Safety end points | 12 months | MACE (death,bleeding, renal failure-yes/no) |
Countries
Spain
Outcome results
None listed