NCT04321044Completed
Genetic Based Analysis in Hypertensive Patients
Genetic Based Analysis of Identifying Predictors of Blood Pressure Response in Hypertensive Patients After Renal Denervation
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
Many attempts to identify predictors of blood pressure response after renal denervation failed to identify a meaningful determination of blood pressure response. These attempts have been based on demographic parameters, clinical parameters, endocrine inflammatory and other biochemical variables, comorbidities and disease factors. So far the only predictor of blood pressure response is the pre-treatment blood pressure. According to Wilder's law the pre-treatment baseline value is always a determinant for any change due to an intervention, irrespective which biological variable is examined. The investigators propose a genetic approach to identify predictors of blood pressure response after renal denervation. Genetic factors are not subject to changes of clinical parameters, previous or current antihypertensive therapy, hypertension associated organ damages, comorbidities and other potential clinical variables.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 17 Feb 2020
- Start date
- 1 Jan 2019
- Primary completion date
- 23 Jul 2020
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- High blood pressure
- NCT number
- NCT04321044
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 1 Jan 2019 to the primary completion date, 23 Jul 2020
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal
- A history of prior renal artery intervention including balloon angioplasty or stenting.
- Multiple main renal arteries in either kidney.
- Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
- Individual is currently enrolled in another investigational drug or device trial
Other illness
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Lab values
- Individual has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD calculation.
- Individual is pregnant, nursing or planning to be pregnant. \[Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.\]
Who the study is looking for
- Individual is ≥ 18 and ≤ 85 years of age.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
- Renal denervation ≥ 6 months
- 24-h ABPM
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Institute of Cardiovascular and Medical Science Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.