HypertensionReDNCT01355055
Sympathetic Activity and Renal Denervation
An observational study of Hypertension, run by Hannover Medical School at 1 site in Germany.
Trial summary
Primary hypothesis: Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension. Secondary hypotheses: 1. The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory hypertension, in whom catheter-based renal denervation is indicated and who are scheduled for this procedure, will be recruited from the outpatient clinic.
Who may be able to join
- Refractory hypertension (as defined by the WHO: poorly controlled hypertension (>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)
- Men or women aged >18 years
- Intact peroneal nerve
- Written informed consent
Who cannot join
- Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.
- Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.
- People in custody
- hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium
- sick sinus syndrome, second or third degree AV block, bradycardia < 50 bpm (contraindication for clonidine)
- endogenous depression (contraindication for clonidine)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover
Karsten Heusser, MD
Julia Reuter, MD
About this study
Official title: Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension
Primary hypothesis:
Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension.
Secondary hypotheses:
- The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.
- Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.
- Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355055
- Sponsor's protocol ID
- DE-MHH-ReD-EK5853
- Acronym
- ReD
- Status last verified
- Mar 2011
- First submitted
- 16 May 2011
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Brinkmann J, Heusser K, Schmidt BM, Menne J, Klein G, Bauersachs J, Haller H, Sweep FC, Diedrich A, Jordan J, Tank J. Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. Hypertension. 2012 Dec;60(6):1485-90. doi: 10.1161/HYPERTENSIONAHA.112.201186. Epub 2012 Oct 8.
PubMed 23045466
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01355055
- Acronym / sponsor ID
- ReD / DE-MHH-ReD-EK5853
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Mar 2011
- First posted
- 17 May 2011 (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.
Primary hypothesis:
Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension.
Secondary hypotheses:
- The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.
- Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.
- Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory hypertension, in whom catheter-based renal denervation is indicated and who are scheduled for this procedure, will be recruited from the outpatient clinic.
Key inclusion criteria (4 listed)
- Refractory hypertension (as defined by the WHO: poorly controlled hypertension (>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)
- Men or women aged >18 years
- Intact peroneal nerve
- Written informed consent
Key exclusion criteria (6 listed)
- Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.
- Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.
- People in custody
- hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium
- sick sinus syndrome, second or third degree AV block, bradycardia < 50 bpm (contraindication for clonidine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Derived from this study: PubMed 23045466Brinkmann J, Heusser K, Schmidt BM, Menne J, Klein G, Bauersachs J, Haller H, Sweep FC, Diedrich A, Jordan J, Tank J. Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. Hypertension. 2012 Dec;60(6):1485-90. doi: 10.1161/HYPERTENSIONAHA.112.201186. Epub 2012 Oct 8.
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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.
1 site 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 Hannover Medical School at 1 site 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: status not confirmed, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heusser Karsten, MD (+495115322723, heusser.karsten@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355055, which also lists 1 linked publication.
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 17 May 2011.