HypertensionNCT04321044
Genetic Based Analysis in Hypertensive Patients
A study testing Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation in people with Hypertension and Renal Denervation, run by University of Erlangen-Nürnberg Medical School at 3 sites in 2 countries.
Trial 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 demographic parameters, clinical parameters, endocrine inflammatory and other biochemical variables, comorbidities and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Renal Denervation, Genetic Predisposition
- What is being tested?
- Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, 91054
Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University
Homburg, Saarland, 66421
United Kingdom1 site
Institute of Cardiovascular and Medical Science
Glasgow, Scotland, G128TA
About this study
Official title: Genetic Based Analysis of Identifying Predictors of Blood Pressure Response in Hypertensive Patients After Renal Denervation
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.
Read the 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. These approaches have been based on demographic parameters, clinical parameters, comorbidities and disease factors as well as numerous endocrine inflammatory and other biochemical variables. Only the pre-treatment blood pressure emerged as a predictor of blood pressure response which is no surprise since 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, e.g. blood pressure, LDL cholesterol, HbA1c and so on.
The investigators suggest a genetic approach to identify predictors of blood pressure response after renal denervation. The rationale is quite simple: 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. By such an approach the investigators previously were very successful to identify several parameters of modulators hypertensive organ damage that could not have been identified by pathophysiological or pharmaceutical maneuvers. THE INVESTIGATORS PREFER TO RUN A GENOM WIDE ASSOCIATION STUDY AND THE PARTNERS IN GLASGOW AND EDINBURGH HAVE THE DEEP KNOWLWEDGE; EXPERIENCE AND CAPACITY TO RUN A NGS (next generation sequencing, so that's the complete genome)) INCLUDING ALL BIOINFORMATICS AND OTHER ANALYSIS
Objective:
The investigators attempt to identify predictors of blood pressure response to renal denervation by using a GWAS (genome wide association study) approach. This allows to identify various suspected and unexpected polymorphism that are of interest and potentially being strong predictors of blood pressure response. By that approach the investigators will identify novel mechanism of action that are important for blood pressure response (by identifying polymorphism that are beyond the classical thinking how renal denervation may exert blood pressure lowering effects).
Study design:
In collaboration with the Homburg Group (Prof. Dr. Felix Mahfoud), the investigators will extract DNA from stored samples of patients with uncontrolled treatment resistant hypertension and perform a genome wide association study analysis (GWAS) in two cohorts: no/low responders vs. high/excellent responders. NGS will be applied by the partners in Glasgow and Edinburgh. All patients with renal denervation will be categorized according to their pretreatment adjusted blood pressure response and the investigators will compare the upper quartile vs. the lower quartile of all patients that has been so far studied in Homburg and Erlangen. By excluding those patients with a medium or average blood pressure response, the investigators will have two distinct response patterns: low/no response vs. high/excellent response.
By applying standard biostatistics analysis, the investigators will come up with a pattern of polymorphism that are significantly different between the two groups. These identified polymorphisms (or a pattern of it) may be refer, not unexpectedly, to renin angiotensin aldosterone system, sodium and water balance, sympathetic nervous system or other endocrine parameters related to hypertension. In addition to that, the investigators may find significant results of polymorphisms involved in other pathophysiologic pathways not related to hypertension (by our current knowledge) and that the Investigators have not thought about to be related to uncontrolled hypertension. These novel mechanism need to be subsequently further analyzed, but they will offer the opportunity to find novel predictors of blood pressure response.
- Conditions
- Hypertension, Renal Denervation, Genetic Predisposition
- Being tested
- Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation
- Keywords
- Renal denervation, Arterial hypertension
- Medical subject headings
- Hypertension, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic based analysis of identifying predictors of blood pressure in patients after renal denervationGenetic
We attempt to idendtify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Other | We attempt to identify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch Receives: Genetic: Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying predictors of systolic blood pressure by 24-h ABPM
To identify predictors of systolic blood pressure response after renal denervation as evaluated by 24-h ABPM by using a GWA (genome wide association) approach.
Measured: 6 months
Secondary outcomes (5)
Identifying predictors of diastolic blood pressure by 24-h ABPM
To identify predictors of diastolic blood pressure response after renal denervation as evaluated by 24-h ABPM by using a GWA (genome wide association) approach.
Measured: 6 months
Identifying predictors of pulse pressure by 24-h ABPM
To identify predictors of pulse pressure response after renal denervation as evaluated by 24-h ABPM by using a GWA (genome wide association) approach.
Measured: 6 months
Identifying predictors of systolic blood pressure by office blood pressure
To identify predictors of systolic blood pressure response after renal denervation as evaluated by office blood pressure by using a GWA (genome wide association) approach.
Measured: 6 months
Identifying predictors of diastolic blood pressure by office blood pressure
To identify predictors of diastolic blood pressure response after renal denervation as evaluated by office blood pressure by using a GWA (genome wide association) approach.
Measured: 6 months
Identifying predictors of pulse pressure by office blood pressure
To identify predictors of pulse pressure response after renal denervation as evaluated by office blood pressure by using a GWA (genome wide association) approach.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jan 2019
- Primary completion23 Jul 2020
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
- Investigators
- Roland E Schmieder, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321044
- Sponsor's protocol ID
- CRC2019GBA
- Status last verified
- Jun 2025
- First submitted
- 17 Feb 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messerli FH, Bangalore S, Schmieder RE. Wilder's principle: pre-treatment value determines post-treatment response. Eur Heart J. 2015 Mar 1;36(9):576-9. doi: 10.1093/eurheartj/ehu467. Epub 2014 Dec 23. No abstract available.
PubMed 25540187Zolk O, Ott C, Fromm MF, Schmieder RE. Effect of the rs168924 single-nucleotide polymorphism in the SLC6A2 catecholamine transporter gene on blood pressure in Caucasians. J Clin Hypertens (Greenwich). 2012 May;14(5):293-8. doi: 10.1111/j.1751-7176.2012.00618.x. Epub 2012 Apr 9.
PubMed 22533655Ott C, Schneider MP, Delles C, Schlaich MP, Hilgers KF, Schmieder RE. Association of (pro)renin receptor gene polymorphism with blood pressure in Caucasian men. Pharmacogenet Genomics. 2011 Jun;21(6):347-9. doi: 10.1097/FPC.0b013e328344cdd2.
PubMed 21346687Ritt M, Ott C, Delles C, Schneider MP, Schmieder RE. Impact of the endothelial nitric oxide synthase gene G894T polymorphism on renal endothelial function in patients with type 2 diabetes. Pharmacogenet Genomics. 2008 Aug;18(8):699-707. doi: 10.1097/FPC.0b013e32830500b1.
PubMed 18622262Ott C, Schwarz T, Hilgers KF, Kreutz R, Schlaich MP, Schmieder RE. Left-ventricular structure and function are influenced by angiotensinogen gene polymorphism (-20 A/C) in young male patients. Am J Hypertens. 2007 Sep;20(9):974-80. doi: 10.1016/j.amjhyper.2007.03.008.
PubMed 17765139Ott C, Titze SI, Schwarz TK, Kreutz R, Hilgers KF, Schmidt BM, Schlaich MP, Schmieder RE. High sodium intake modulates left ventricular mass in patients with G expression of +1675 G/A angiotensin II receptor type 2 gene. J Hypertens. 2007 Aug;25(8):1627-32. doi: 10.1097/HJH.0b013e3281cd40f5.
PubMed 17620959Zolk O, Jacobi J, Pahl A, Fromm MF, Schmieder RE. MDR1 genotype-dependent regulation of the aldosterone system in humans. Pharmacogenet Genomics. 2007 Feb;17(2):137-44. doi: 10.1097/01.fpc.0000239969.46594.d0.
PubMed 17301693Fromm MF, Schmidt BM, Pahl A, Jacobi J, Schmieder RE. CYP3A5 genotype is associated with elevated blood pressure. Pharmacogenet Genomics. 2005 Oct;15(10):737-41. doi: 10.1097/01.fpc.0000175599.49764.98.
PubMed 16141800Hilgers KF, Delles C, Veelken R, Schmieder RE. Angiotensinogen gene core promoter variants and non-modulating hypertension. Hypertension. 2001 Dec 1;38(6):1250-4. doi: 10.1161/hy1201.096545.
PubMed 11751698Delles C, Erdmann J, Jacobi J, Hilgers KF, Fleck E, Regitz-Zagrosek V, Schmieder RE. Aldosterone synthase (CYP11B2) -344 C/T polymorphism is associated with left ventricular structure in human arterial hypertension. J Am Coll Cardiol. 2001 Mar 1;37(3):878-84. doi: 10.1016/s0735-1097(00)01174-8.
PubMed 11693765Schmieder RE, Erdmann J, Delles C, Jacobi J, Fleck E, Hilgers K, Regitz-Zagrosek V. Effect of the angiotensin II type 2-receptor gene (+1675 G/A) on left ventricular structure in humans. J Am Coll Cardiol. 2001 Jan;37(1):175-82. doi: 10.1016/s0735-1097(00)01063-9.
PubMed 11153734
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Based Analysis of Identifying Predictors of Blood Pressure Response in Hypertensive Patients After Renal Denervation
- ClinicalTrials.gov ID
- NCT04321044
- Acronym / sponsor ID
- CRC2019GBA
- Conditions
- Hypertension, Renal Denervation, Genetic Predisposition
- Keywords
- Renal denervation, Arterial hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. These approaches have been based on demographic parameters, clinical parameters, comorbidities and disease factors as well as numerous endocrine inflammatory and other biochemical variables. Only the pre-treatment blood pressure emerged as a predictor of blood pressure response which is no surprise since 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, e.g. blood pressure, LDL cholesterol, HbA1c and so on.
The investigators suggest a genetic approach to identify predictors of blood pressure response after renal denervation. The rationale is quite simple: 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. By such an approach the investigators previously were very successful to identify several parameters of modulators hypertensive organ damage that could not have been identified by pathophysiological or pharmaceutical maneuvers. THE INVESTIGATORS PREFER TO RUN A GENOM WIDE ASSOCIATION STUDY AND THE PARTNERS IN GLASGOW AND EDINBURGH HAVE THE DEEP KNOWLWEDGE; EXPERIENCE AND CAPACITY TO RUN A NGS (next generation sequencing, so that's the complete genome)) INCLUDING ALL BIOINFORMATICS AND OTHER ANALYSIS
Objective:
The investigators attempt to identify predictors of blood pressure response to renal denervation by using a GWAS (genome wide association study) approach. This allows to identify various suspected and unexpected polymorphism that are of interest and potentially being strong predictors of blood pressure response. By that approach the investigators will identify novel mechanism of action that are important for blood pressure response (by identifying polymorphism that are beyond the classical thinking how renal denervation may exert blood pressure lowering effects).
Study design:
In collaboration with the Homburg Group (Prof. Dr. Felix Mahfoud), the investigators will extract DNA from stored samples of patients with uncontrolled treatment resistant hypertension and perform a genome wide association study analysis (GWAS) in two cohorts: no/low responders vs. high/excellent responders. NGS will be applied by the partners in Glasgow and Edinburgh. All patients with renal denervation will be categorized according to their pretreatment adjusted blood pressure response and the investigators will compare the upper quartile vs. the lower quartile of all patients that has been so far studied in Homburg and Erlangen. By excluding those patients with a medium or average blood pressure response, the investigators will have two distinct response patterns: low/no response vs. high/excellent response.
By applying standard biostatistics analysis, the investigators will come up with a pattern of polymorphism that are significantly different between the two groups. These identified polymorphisms (or a pattern of it) may be refer, not unexpectedly, to renin angiotensin aldosterone system, sodium and water balance, sympathetic nervous system or other endocrine parameters related to hypertension. In addition to that, the investigators may find significant results of polymorphisms involved in other pathophysiologic pathways not related to hypertension (by our current knowledge) and that the Investigators have not thought about to be related to uncontrolled hypertension. These novel mechanism need to be subsequently further analyzed, but they will offer the opportunity to find novel predictors of blood pressure response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Other | Genetic: Genetic based analysis of identifying predictors of blood pressure in patients after renal denervationWe attempt to identify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Individual has renal artery anatomy that is ineligible for treatment including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic based analysis of identifying predictors of blood pressure in patients after renal denervationWe attempt to idendtify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch. | Genetic | Renal Denervation |
Primary outcome
Identifying predictors of systolic blood pressure by 24-h ABPM
Time frame: 6 months
To identify predictors of systolic blood pressure response after renal denervation as evaluated by 24-h ABPM by using a GWA (genome wide association) approach.
5 secondary outcomes
Identifying predictors of diastolic blood pressure by 24-h ABPM
Time frame: 6 months
Identifying predictors of pulse pressure by 24-h ABPM
Time frame: 6 months
Identifying predictors of systolic blood pressure by office blood pressure
Time frame: 6 months
Identifying predictors of diastolic blood pressure by office blood pressure
Time frame: 6 months
Identifying predictors of pulse pressure by office blood pressure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 25540187Messerli FH, Bangalore S, Schmieder RE. Wilder's principle: pre-treatment value determines post-treatment response. Eur Heart J. 2015 Mar 1;36(9):576-9. doi: 10.1093/eurheartj/ehu467. Epub 2014 Dec 23. No abstract available.
- Background: PubMed 22533655Zolk O, Ott C, Fromm MF, Schmieder RE. Effect of the rs168924 single-nucleotide polymorphism in the SLC6A2 catecholamine transporter gene on blood pressure in Caucasians. J Clin Hypertens (Greenwich). 2012 May;14(5):293-8. doi: 10.1111/j.1751-7176.2012.00618.x. Epub 2012 Apr 9.
- Background: PubMed 21346687Ott C, Schneider MP, Delles C, Schlaich MP, Hilgers KF, Schmieder RE. Association of (pro)renin receptor gene polymorphism with blood pressure in Caucasian men. Pharmacogenet Genomics. 2011 Jun;21(6):347-9. doi: 10.1097/FPC.0b013e328344cdd2.
- Background: PubMed 18622262Ritt M, Ott C, Delles C, Schneider MP, Schmieder RE. Impact of the endothelial nitric oxide synthase gene G894T polymorphism on renal endothelial function in patients with type 2 diabetes. Pharmacogenet Genomics. 2008 Aug;18(8):699-707. doi: 10.1097/FPC.0b013e32830500b1.
- Background: PubMed 17765139Ott C, Schwarz T, Hilgers KF, Kreutz R, Schlaich MP, Schmieder RE. Left-ventricular structure and function are influenced by angiotensinogen gene polymorphism (-20 A/C) in young male patients. Am J Hypertens. 2007 Sep;20(9):974-80. doi: 10.1016/j.amjhyper.2007.03.008.
- Background: PubMed 17620959Ott C, Titze SI, Schwarz TK, Kreutz R, Hilgers KF, Schmidt BM, Schlaich MP, Schmieder RE. High sodium intake modulates left ventricular mass in patients with G expression of +1675 G/A angiotensin II receptor type 2 gene. J Hypertens. 2007 Aug;25(8):1627-32. doi: 10.1097/HJH.0b013e3281cd40f5.
- Background: PubMed 17301693Zolk O, Jacobi J, Pahl A, Fromm MF, Schmieder RE. MDR1 genotype-dependent regulation of the aldosterone system in humans. Pharmacogenet Genomics. 2007 Feb;17(2):137-44. doi: 10.1097/01.fpc.0000239969.46594.d0.
- Background: PubMed 16141800Fromm MF, Schmidt BM, Pahl A, Jacobi J, Schmieder RE. CYP3A5 genotype is associated with elevated blood pressure. Pharmacogenet Genomics. 2005 Oct;15(10):737-41. doi: 10.1097/01.fpc.0000175599.49764.98.
- Background: PubMed 11751698Hilgers KF, Delles C, Veelken R, Schmieder RE. Angiotensinogen gene core promoter variants and non-modulating hypertension. Hypertension. 2001 Dec 1;38(6):1250-4. doi: 10.1161/hy1201.096545.
- Background: PubMed 11693765Delles C, Erdmann J, Jacobi J, Hilgers KF, Fleck E, Regitz-Zagrosek V, Schmieder RE. Aldosterone synthase (CYP11B2) -344 C/T polymorphism is associated with left ventricular structure in human arterial hypertension. J Am Coll Cardiol. 2001 Mar 1;37(3):878-84. doi: 10.1016/s0735-1097(00)01174-8.
- Background: PubMed 11153734Schmieder RE, Erdmann J, Delles C, Jacobi J, Fleck E, Hilgers K, Regitz-Zagrosek V. Effect of the angiotensin II type 2-receptor gene (+1675 G/A) on left ventricular structure in humans. J Am Coll Cardiol. 2001 Jan;37(1):175-82. doi: 10.1016/s0735-1097(00)01063-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E Schmieder, MD principal investigator
University Hospital Erlangen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation in people with Hypertension and Renal Denervation, run by University of Erlangen-Nürnberg Medical School at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying predictors of systolic blood pressure by 24-h ABPM (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321044, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.