Evaluating renal denervation for patients with sympathetic dysautonomia and hypertension
Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY
This study is testing if a procedure called renal denervation can help people with high blood pressure and nervous system issues feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St Carlos Hospital, Madrid, Spain Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT04314557 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the effects of renal denervation in patients suffering from hypertension and sympathetic dysautonomia. It focuses on assessing clinical outcomes such as blood pressure levels, quality of life, and catecholamine levels in patients who are poorly controlled on antihypertensive medication. The study will utilize ambulatory blood pressure monitoring (ABPM) to measure blood pressure variability, specifically looking for significant deviations in systolic and diastolic blood pressure. The ultimate goal is to evaluate the safety and efficacy of this intervention in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with poorly controlled hypertension, increased blood pressure variability, and suitable renal artery anatomy.
Not a fit: Patients who are not on antihypertensive medication or those without significant blood pressure variability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-control hypertension and improve their overall quality of life.
How similar studies have performed: While renal denervation has been explored in various studies, this specific approach focusing on sympathetic dysautonomia and blood pressure variability is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.