HypertensionPhase 3PRAGUE-15NCT01560312
Renal Denervation in Refractory Hypertension
A Phase 3 study testing Renal denervation (Symplicity® Catheter System™) in people with Hypertension and Resistant to Conventional Therapy, run by Charles University, Czech Republic at 3 sites in Czechia.
Trial summary
Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including… 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 (Symplicity® Catheter System™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesCzechia
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 3
- 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
Who may be able to join
- Refractory hypertension with office SBP > 140 mmHg
- SBP > 130 during 24-hours Holter blood pressure monitoring
- Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
- Age > 18 years
- Signed informed consent
Who cannot join
- Secondary forms of hypertension
- Chronic renal disease (serum creatinine > 200 umol/l)
- Pregnancy
- History of myocardial infarction or stroke in last 6 months
- Severe valvular stenotic disease
- Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter < 4 mm or length < 20 mm
- Increased bleeding risk (thrombocytopenia < 50, INR > 1.5)
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Cardiocenter, University Hospital Olomouc
Olomouc
Jiri Widimsky
Prague
Cardiocenter Podlesi
Třinec
About this study
Official title: Renal Denervation - Hope for Patients With Refractory Hypertension?
Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.
- Conditions
- Hypertension, Resistant to Conventional Therapy
- Being tested
- Renal denervation (Symplicity® Catheter System™)
- Keywords
- Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome
- 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 (Symplicity® Catheter System™)Device
4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization) Receives: Device: Renal denervation (Symplicity® Catheter System™) |
| Medical treatment | No intervention | Conventional antihypertensive treatment including spironolactone (if not contraindicated). One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure difference
Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.
Measured: 6 months
Secondary outcomes (3)
Blood pressure differences similar to primary outcome
Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office.
Measured: 1 year, 2 years, 3 years
Change of blood laboratory parameters and renal function
changes in blood concentrations of renin, aldosterone, metanephrines and renal function
Measured: 6 months, 1, 2, 3 years
Post-denervation renal anatomy assessment
CT angiography will be performed 1 year after RDN
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague, University Hospital Olomouc, Cardiocenter Podlesí, Trinec, Czech Republic
- Responsible party
- Principal investigator, Petr Widimsky, MD, Charles University, Czech Republic
- Investigators
- Petr Widimsky, Prof, MD, Principal investigator, Charles University, Prague, Czech RepublicJiri Widimsky, Prof.MD., Principal investigator, General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560312
- Sponsor's protocol ID
- Charles University
- Acronym
- PRAGUE-15
- Status last verified
- Jan 2019
- First submitted
- 19 Mar 2012
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation - Hope for Patients With Refractory Hypertension?
- ClinicalTrials.gov ID
- NCT01560312
- Acronym / sponsor ID
- PRAGUE-15 / Charles University
- Conditions
- Hypertension, Resistant to Conventional Therapy
- Keywords
- Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague, University Hospital Olomouc, Cardiocenter Podlesí, Trinec, Czech Republic
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Mar 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.
Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Renal denervation (Symplicity® Catheter System™)Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization) |
| Medical treatment | No intervention | –Conventional antihypertensive treatment including spironolactone (if not contraindicated). One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refractory hypertension with office SBP > 140 mmHg
- SBP > 130 during 24-hours Holter blood pressure monitoring
- Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
- Age > 18 years
- Signed informed consent
Key exclusion criteria (7 listed)
- Secondary forms of hypertension
- Chronic renal disease (serum creatinine > 200 umol/l)
- Pregnancy
- History of myocardial infarction or stroke in last 6 months
- Severe valvular stenotic 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 denervation (Symplicity® Catheter System™)4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic) | Device | Renal denervation |
Primary outcome
Blood pressure difference
Time frame: 6 months
Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.
3 secondary outcomes
Blood pressure differences similar to primary outcome
Time frame: 1 year, 2 years, 3 years
Change of blood laboratory parameters and renal function
Time frame: 6 months, 1, 2, 3 years
Post-denervation renal anatomy assessment
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Petr Widimsky, Prof, MD principal investigator
Charles University, Prague, Czech Republic
Jiri Widimsky, Prof.MD. principal investigator
General University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal denervation (Symplicity® Catheter System™) in people with Hypertension and Resistant to Conventional Therapy, run by Charles University, Czech Republic at 3 sites in Czechia.
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 7 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: stopped early, as of the sponsor's last update on 1 Feb 2019. 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 Czechia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.). Results are not available in the source record.
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?
Blood pressure difference (time frame: 6 months). 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 1 Feb 2019.