Resistant HypertensionRENSYMPISNCT01785732
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
A study testing Renal Denervation in people with Resistant Hypertension, run by The Hospital District of Satakunta at 1 site in Finland.
Trial summary
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension. The purpose of RENSYMPIS is to study the effects of renal denervation on: 1. Cardiovascular function 2. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Renal Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Jan 2016
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use)
- Age 30- 69 years
- Written informed consent
Who cannot join
- Secondary hypertension
- Pseudohypertension
- Pregnancy
- Renal insufficiency (GFR <45ml/min)
- Clinically significant stenotic valvular disease
- Oral anticoagulation
Show all 10Show fewer
- CCS III-IV symptoms or CABG/PCI in previous 6 months
- Prior stroke
- Contrast agent allergy
- inappropriate renal artery anatomy (< 4mm diameter, < 20mm length)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Satakunta Central Hospital
Pori
Tuomas Paana, M.D, +358 2 6277100, tuomas.paana@satshp.fi
Tuomas Paana, M.D.
About this study
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.
The purpose of RENSYMPIS is to study the effects of renal denervation on:
- Cardiovascular function
- Metabolic factors
- Inflammatory and endocrine factors
- Coagulation
- Sleep
- Conditions
- Resistant Hypertension
- Being tested
- Renal Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Sympathetic renal denervation via renal arteries
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Active comparator | Patients are randomized to renal denervation Receives: Procedure: Renal Denervation |
| Optimization of medical therapy | No intervention | Antihypertensive treatment is optimized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office blood pressure
Measured: 2 years
Secondary outcomes (3)
Ambulatory blood pressure
Measured: 2 years
Insulin resistance
Measured: 2 years
Endothelial function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785732
- Sponsor's protocol ID
- SA-007
- Acronym
- RENSYMPIS
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
- ClinicalTrials.gov ID
- NCT01785732
- Acronym / sponsor ID
- RENSYMPIS / SA-007
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 7 Feb 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.
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.
The purpose of RENSYMPIS is to study the effects of renal denervation on:
- Cardiovascular function
- Metabolic factors
- Inflammatory and endocrine factors
- Coagulation
- Sleep
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Active comparator | Procedure: Renal DenervationPatients are randomized to renal denervation |
| Optimization of medical therapy | No intervention | –Antihypertensive treatment is optimized |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use)
- Age 30- 69 years
- Written informed consent
Key exclusion criteria (10 listed)
- Secondary hypertension
- Pseudohypertension
- Pregnancy
- Renal insufficiency (GFR <45ml/min)
- Clinically significant stenotic valvular disease
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 DenervationSympathetic renal denervation via renal arteries | Procedure or surgery | Renal denervation |
Primary outcome
Office blood pressure
Time frame: 2 years
3 secondary outcomes
Ambulatory blood pressure
Time frame: 2 years
Insulin resistance
Time frame: 2 years
Endothelial function
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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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?
A study testing Renal Denervation in people with Resistant Hypertension, run by The Hospital District of Satakunta at 1 site in Finland.
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 3 inclusion and 10 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 11 Feb 2013. 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 Finland. 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 Tuomas Paana, M.D. (+358 2 6277100, tuomas.paana@satshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office blood pressure (time frame: 2 years). 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 11 Feb 2013.