Status:
COMPLETED
Genetic Based Analysis in Hypertensive Patients
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Hypertension
Renal Denervation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 dem...
Detailed Description
Background: Up to now numerous attempts to identify predictors of blood pressure response after renal denervation failed to identify a meaningful and consistent determinant of blood pressure response...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD calculation.
- 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 a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
- 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 is pregnant, nursing or planning to be pregnant. \[Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.\]
- 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.
- Individual is currently enrolled in another investigational drug or device trial
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04321044
Start Date
January 1 2019
End Date
December 31 2023
Last Update
June 13 2025
Active Locations (3)
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1
Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University
Homburg, Saarland, Germany, 66421
2
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, Germany, 91054
3
Institute of Cardiovascular and Medical Science
Glasgow, Scotland, United Kingdom, G128TA