Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT04314557
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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04314557
Study Brief:
Protocol Section:
NCT04314557