HypertensionNCT01687725
Renal Denervation in Treatment Resistant Hypertension
An observational study of Hypertension, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal denervation using Symplicity Catheter system
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2010to Dec 2018
- Phase
- Observational
- 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
Study population: treatment resistant hypertensive adults
Who may be able to join
- treatment resistant hypertension
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Who cannot join
- chronic kidney disease 3 - 5
- any contradictions for MRI
- claustrophobia
- strabismus
- severe ocular diseases
- history of epilepsia
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, 91054
Klinik für Innere Medizin, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
About this study
In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Read more
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months
- Conditions
- Hypertension
- Being tested
- Renal denervation using Symplicity Catheter system
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation using Symplicity Catheter systemDevice
percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Renal denervation using Symplicity Catheter system Receives: Device: Renal denervation using Symplicity Catheter system |
What is being measured
The primary outcome is the main question the study is designed to answer.
office BP
change in office blood pressure from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
24-ABPM
change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
Magnetic resonance imaging (MRI)
- change in total sodium content measured by MRI from baseline to 6 months post-renal denervation
- change in renal perfusion measured by MRI from baseline to 3 months post-renal denervation
Measured: baseline, 3 and 6 months
Albuminuria
change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
Systemic RAS activity
- change in sodium, potassium and creatinine from baseline to 6 months post-renal denervation
- change in aldosterone excretion from baseline to 6 months post-renal denervation
- change in sodium/potassium ratio from baseline to 6 months post-renal denervation
- change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
Vascular structure and function of large and small arteries
- change in flow-mediated vasodilation (FMD)from baseline to 6 months post-renal denervation
- change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal denervation
- change in funduscopy from baseline to 6 months post-renal denervation
- change in pulse wave analysis (PWA) from baseline to 6 months post-renal denervation
- change in pulse wave velocity (PWV) from baseline to 6 months post-renal denervation
- change in urinary albumine/creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
Local RAS activity
change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal denervation
Measured: baseline, 6 months
Secondary outcomes (6)
BP
- change in office BP from baseline to 3 and 12 months post-renal denervation
- change in 24 hour ABPM from baseline to 3 and 12 months post-renal denervation
Measured: 3 and 12 months
MRI
- change in total sodium content measured by MRI from baseline to 12 months post-renal denervation
- change in renal perfusion measured by MRI spin labelling technique from baseline to 1 day post-renal denervation
Measured: 1 day and 12 months
Local RAS activity
change urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day, 3 and 12 months post-renal denervation
Measured: 1 day, 3 and 12 months
Systemic RAS activity
- change in sodium potassium and creatinine from baseline to 1 day, 3 and 12 months post-renal denervation
- change in aldosterone excretion from baseline to 1 day, 3 and 12 months post-renal denervation
- change in sodium/potassium ratio from baseline to 1 day, 3 and 12 months post-renal denervation
- change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 1 day, 3 and 12 months post-renal denervation
Measured: 1 day, 3 and 12 months
Albuminuria
- change in albuminuria from baseline to 3 and 12 months post-renal denervation
Measured: 3 and 12 months
Vascular structure and function of large and small arteries
- change in flow mediated vasodilation (FMD) from baseline to 12 months post-renal denervation
- change in scanning laser Doppler flowmetry (SLDF) from baseline to 12 months post-renal denervation
- change in funduscopy from baseline to 3 and 12 months post-renal denervation
- change in pulse wave analysis (PWA) from baseline to 12 months post-renal denervation
- change in pulse wave velocity (PWV) from baseline to 12 months post-renal denervation
- change in urinary albumine/creatinine ratio of the morning spot urine sample from baseline to 3 and 12 months post-renal denervation
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startNov 2010
- Primary completionJun 2018
- Study completionDec 2018
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.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687725
- Sponsor's protocol ID
- RD-TRH
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2012
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ott C, Harazny JM, Schmid A, Ditting T, Veelken R, Bladowski M, Michelson G, Uder M, Schmieder RE. Retinal microperfusion after renal denervation in treatment-resistant hypertensive patients. Clin Res Cardiol. 2015 Sep;104(9):782-9. doi: 10.1007/s00392-015-0845-0. Epub 2015 Apr 28.
PubMed 25916737Ott C, Mahfoud F, Schmid A, Ewen S, Toennes SW, Meyer MR, Helfer AG, Maurer HH, Ditting T, Veelken R, Zivanovic I, Uder M, Bohm M, Schmieder RE. The effect of renal denervation in moderate treatment-resistant hypertension with confirmed medication adherence. J Hypertens. 2016 Dec;34(12):2475-2479. doi: 10.1097/HJH.0000000000001110.
PubMed 27607458Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
PubMed 25923731Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
PubMed 39526682Guenes-Altan M, Schmid A, Kannenkeril D, Linz P, Ott C, Bosch A, Schiffer M, Uder M, Schmieder RE. Skin sodium content as a predictor of blood pressure response to renal denervation. Hypertens Res. 2024 Feb;47(2):361-371. doi: 10.1038/s41440-023-01450-4. Epub 2023 Oct 25.
PubMed 37880499Bosch A, Schmid A, Ott C, Kannenkeril D, Karg MV, Ditting T, Veelken R, Uder M, Schmieder RE. Copeptin Levels in Patients With Treatment-Resistant Hypertension Before and 6 Months After Renal Denervation. Am J Hypertens. 2020 Feb 22;33(2):182-189. doi: 10.1093/ajh/hpz155.
PubMed 31555795Ott C, Kopp C, Dahlmann A, Schmid A, Linz P, Cavallaro A, Hammon M, Ditting T, Veelken R, Uder M, Titze J, Schmieder RE. Impact of renal denervation on tissue Na+ content in treatment-resistant hypertension. Clin Res Cardiol. 2018 Jan;107(1):42-48. doi: 10.1007/s00392-017-1156-4. Epub 2017 Aug 28.
PubMed 28845508Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
PubMed 26873693Ott C, Schmid A, Toennes SW, Ditting T, Veelken R, Uder M, Schmieder RE. Central pulse pressure predicts BP reduction after renal denervation in patients with treatment-resistant hypertension. EuroIntervention. 2015 May;11(1):110-6. doi: 10.4244/EIJV11I1A19.
PubMed 25982653Ott C, Mahfoud F, Schmid A, Ditting T, Veelken R, Ewen S, Ukena C, Uder M, Bohm M, Schmieder RE. Improvement of albuminuria after renal denervation. Int J Cardiol. 2014 May 1;173(2):311-5. doi: 10.1016/j.ijcard.2014.03.017. Epub 2014 Mar 15.
PubMed 24681017Ott C, Mahfoud F, Schmid A, Ditting T, Sobotka PA, Veelken R, Spies A, Ukena C, Laufs U, Uder M, Bohm M, Schmieder RE. Renal denervation in moderate treatment-resistant hypertension. J Am Coll Cardiol. 2013 Nov 12;62(20):1880-6. doi: 10.1016/j.jacc.2013.06.023. Epub 2013 Jul 10.
PubMed 23850901
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Treatment Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01687725
- Acronym / sponsor ID
- RD-TRH
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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.
In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | – | Device: Renal denervation using Symplicity Catheter systemRenal denervation using Symplicity Catheter system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- treatment resistant hypertensive adults
Key inclusion criteria (4 listed)
- treatment resistant hypertension
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Key exclusion criteria (6 listed)
- chronic kidney disease 3 - 5
- any contradictions for MRI
- claustrophobia
- strabismus
- severe ocular diseases
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 |
|---|---|---|
| Renal denervation using Symplicity Catheter systempercutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system | Device | Renal denervation |
Primary outcome
office BP
Time frame: baseline, 6 months
change in office blood pressure from baseline to 6 months post-renal denervation
24-ABPM
Time frame: baseline, 6 months
change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation
Magnetic resonance imaging (MRI)
Time frame: baseline, 3 and 6 months
* change in total sodium content measured by MRI from baseline to 6 months post-renal denervation * change in renal perfusion measured by MRI from baseline to 3 months post-renal denervation
Albuminuria
Time frame: baseline, 6 months
change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation
Systemic RAS activity
Time frame: baseline, 6 months
* change in sodium, potassium and creatinine from baseline to 6 months post-renal denervation * change in aldosterone excretion from baseline to 6 months post-renal denervation * change in sodium/potassium ratio from baseline to 6 months post-renal denervation * change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal denervation
Vascular structure and function of large and small arteries
Time frame: baseline, 6 months
* change in flow-mediated vasodilation (FMD)from baseline to 6 months post-renal denervation * change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal denervation * change in funduscopy from baseline to 6 months post-renal denervation * change in pulse wave analysis (PWA) from baseline to 6 months post-renal denervation * change in pulse wave velocity (PWV) from baseline to 6 months post-renal denervation * change in urinary albumine/creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal denervation
Local RAS activity
Time frame: baseline, 6 months
change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal denervation
6 secondary outcomes
BP
Time frame: 3 and 12 months
MRI
Time frame: 1 day and 12 months
Local RAS activity
Time frame: 1 day, 3 and 12 months
Systemic RAS activity
Time frame: 1 day, 3 and 12 months
Albuminuria
Time frame: 3 and 12 months
Vascular structure and function of large and small arteries
Time frame: 3 and 12 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 18 Feb 2020.
- Background: PubMed 25916737Ott C, Harazny JM, Schmid A, Ditting T, Veelken R, Bladowski M, Michelson G, Uder M, Schmieder RE. Retinal microperfusion after renal denervation in treatment-resistant hypertensive patients. Clin Res Cardiol. 2015 Sep;104(9):782-9. doi: 10.1007/s00392-015-0845-0. Epub 2015 Apr 28.
- Background: PubMed 27607458Ott C, Mahfoud F, Schmid A, Ewen S, Toennes SW, Meyer MR, Helfer AG, Maurer HH, Ditting T, Veelken R, Zivanovic I, Uder M, Bohm M, Schmieder RE. The effect of renal denervation in moderate treatment-resistant hypertension with confirmed medication adherence. J Hypertens. 2016 Dec;34(12):2475-2479. doi: 10.1097/HJH.0000000000001110.
- Background: PubMed 25923731Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
- Derived from this study: PubMed 39526682Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
- Derived from this study: PubMed 37880499Guenes-Altan M, Schmid A, Kannenkeril D, Linz P, Ott C, Bosch A, Schiffer M, Uder M, Schmieder RE. Skin sodium content as a predictor of blood pressure response to renal denervation. Hypertens Res. 2024 Feb;47(2):361-371. doi: 10.1038/s41440-023-01450-4. Epub 2023 Oct 25.
- Derived from this study: PubMed 31555795Bosch A, Schmid A, Ott C, Kannenkeril D, Karg MV, Ditting T, Veelken R, Uder M, Schmieder RE. Copeptin Levels in Patients With Treatment-Resistant Hypertension Before and 6 Months After Renal Denervation. Am J Hypertens. 2020 Feb 22;33(2):182-189. doi: 10.1093/ajh/hpz155.
- Derived from this study: PubMed 28845508Ott C, Kopp C, Dahlmann A, Schmid A, Linz P, Cavallaro A, Hammon M, Ditting T, Veelken R, Uder M, Titze J, Schmieder RE. Impact of renal denervation on tissue Na+ content in treatment-resistant hypertension. Clin Res Cardiol. 2018 Jan;107(1):42-48. doi: 10.1007/s00392-017-1156-4. Epub 2017 Aug 28.
- Derived from this study: PubMed 26873693Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
- Derived from this study: PubMed 25982653Ott C, Schmid A, Toennes SW, Ditting T, Veelken R, Uder M, Schmieder RE. Central pulse pressure predicts BP reduction after renal denervation in patients with treatment-resistant hypertension. EuroIntervention. 2015 May;11(1):110-6. doi: 10.4244/EIJV11I1A19.
- Derived from this study: PubMed 24681017Ott C, Mahfoud F, Schmid A, Ditting T, Veelken R, Ewen S, Ukena C, Uder M, Bohm M, Schmieder RE. Improvement of albuminuria after renal denervation. Int J Cardiol. 2014 May 1;173(2):311-5. doi: 10.1016/j.ijcard.2014.03.017. Epub 2014 Mar 15.
- Derived from this study: PubMed 23850901Ott C, Mahfoud F, Schmid A, Ditting T, Sobotka PA, Veelken R, Spies A, Ukena C, Laufs U, Uder M, Bohm M, Schmieder RE. Renal denervation in moderate treatment-resistant hypertension. J Am Coll Cardiol. 2013 Nov 12;62(20):1880-6. doi: 10.1016/j.jacc.2013.06.023. Epub 2013 Jul 10.
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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 of Erlangen-Nürnberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
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 6 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
office BP (time frame: baseline, 6 months). The study lists 7 primary outcomes in all. 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 NCT01687725, 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 18 Feb 2020.