Hypertension, Resistant to Conventional TherapyRETREATNCT01834118
Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
An observational study of Hypertension, Resistant to Conventional Therapy, run by Cardiovascular Center Frankfurt at 1 site in Germany.
Trial summary
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Renal Denervation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Apr 2016
- How long will I take part?
- 1 Year
- 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 treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.
Who may be able to join
- Individual is ≥18 years old
- Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
- Systolic Office based blood pressure ≥140mmHg
- Individual receives 3 or more antihypertensive drugs including one diuretic
- Individual is willing to provide written informed consent to participate in this study
Who cannot join
- Individual has hypertension secondary to an identifiable and treatable cause
- Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
- Individual is pregnant, nursing or planning to be pregnant
- Renal artery abnormalities which may affect the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.
Read the detailed description
Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
- Being tested
- Renal Denervation
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Also called Renal sympathetic nerve ablation
Sympathetic nerve ablation via transcatheter renal denervation
What is being measured
The primary outcome is the main question the study is designed to answer.
Office Blood pressure measurement
Measured: up to1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- 10 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cardiovascular Center Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt
- Investigators
- Horst Sievert, M.D., Principal investigator, Cardiovascular Center Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834118
- Sponsor's protocol ID
- CVC-001
- Acronym
- RETREAT
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
- ClinicalTrials.gov ID
- NCT01834118
- Acronym / sponsor ID
- RETREAT / CVC-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiovascular Center FrankfurtUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Apr 2013 (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.
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.
Detailed description
Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.
Key inclusion criteria (5 listed)
- Individual is ≥18 years old
- Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
- Systolic Office based blood pressure ≥140mmHg
- Individual receives 3 or more antihypertensive drugs including one diuretic
- Individual is willing to provide written informed consent to participate in this study
Key exclusion criteria (4 listed)
- Individual has hypertension secondary to an identifiable and treatable cause
- Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
- Individual is pregnant, nursing or planning to be pregnant
- Renal artery abnormalities which may affect the procedure
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 DenervationAlso: Renal sympathetic nerve ablationSympathetic nerve ablation via transcatheter renal denervation | Procedure or surgery | – |
Primary outcome
Office Blood pressure measurement
Time frame: up to1 year
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 28 Jul 2016.
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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.
Horst Sievert, M.D. principal investigator
Cardiovascular Center Frankfurt
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, Resistant to Conventional Therapy, run by Cardiovascular Center Frankfurt 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 5 inclusion and 4 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 28 Jul 2016. 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?
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 Blood pressure measurement (time frame: up to1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2016.