Hypertension, RenalNCT04722159
Clinical Outcome of Patients With Resistant Hypertension Undergoing Renal Denervation
An observational study of Hypertension, Renal, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Studies on the impact of RDN on cardiovascular surrogate markers have shown a variety of beneficial effects: RDN is associated with a decrease blood pressure (BP), left ventricular mass (LVM), a reduction in aortic pulse-wave velocity and BP variability as well as an increase in heart rate-recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Renal
- What is being tested?
- Renal denervation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to Aug 2021
- How long will I take part?
- 6 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with resistant hypertension, registered in either the The Swedish Registry for Renal Denervation or the Swedish Primary Care Cardiovascular Database (SPCCD).
Who may be able to join
- Patients registered in the Swedish Registry for Renal Denervation or SPCCD, fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs).
Who cannot join
- Any patient who has withdrawn consent from being in either registry.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlrenska University Hospital
Gothenburg, 41345
Sebastian Völz, PhD
Sebastian Völz, PhD
About this study
Official title: Clinical Outcome of Patients With Resistant Hypertension Undergoing Renal Denervation: A Report From the Swedish Registry for Renal Denervation
Studies on the impact of RDN on cardiovascular surrogate markers have shown a variety of beneficial effects: RDN is associated with a decrease blood pressure (BP), left ventricular mass (LVM), a reduction in aortic pulse-wave velocity and BP variability as well as an increase in heart rate-recovery. Several of these aspects have been observed independently of office BP response, and might be mediated by a direct modulation of the sympathetic nervous system. Moreover, several independent real - world registries have shown an association of renal denervation and sustained blood pressure reductions of clinically relevant magnitude up to 36 months of follow - up.
Whether the sum of these effects may translate into an improvement of clinical outcomes remains unclear and constitutes the primary subject of proposed registry based study.
Read the detailed description
Two registries interlinked by the Swedish personal identification number The Swedish Registry for Renal Denervation: The Swedish Registry for Renal Denervation is an investigator - initiated academic online database, developed by our group and supported by the Swedish authorities. The registry contains 130 variables summarizing baseline patient characteristics, procedural details, as well as follow - up data. The database contains patient data from the seven Swedish university hospitals that have performed RDN since 2011 exclusively, thereby providing a nation-wide data set with a follow-up of up to five years.
The Swedish Primary Care Cardiovascular Database (SPCCD):
SPCCD comprises data from 75 000 patients diagnosed with hypertension collected at primary care centres in the Stockholm and Skaraborg region during the time period 2001-2008. Patient baseline characteristics may be derived from the individual electronic medical records.
Study objectives:
- To describe the incidence of the composite end-point of myocardial infarction, stroke, heart failure and cardiovascular death in patients with resistant hypertension treated with RDN as compared to conservatively treated resistant hypertensives.
- Our hypothesis is that RDN treated individuals will show a lower event rate in regard to the composite clinical end - point during the first 5 years of follow - up when compared to conservatively treated individuals with resistant hypertension.
Inclusion criteria:
- Patients fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period period of at least 5 years (SPCCD).
Methods and statistical analysis:
The primary end point of this study is the composite of myocardial infarction, stroke, heart failure and cardiovascular death in patients with resistant hypertension having undergone renal denervation (n = 300), compared to a control group of conservatively treated resistant hypertensives from the SPCCD. The necessary information about the diagnose codes for the events relevant for the primary end - point is made possible through the unique Swedish personal identification number and available through the Swedish population based registries for both the case - and control - group.
In order to adjust for differences in the baseline variables age, sex, diabetes, coronary artery disease, heart failure, baseline blood pressure, duration of hypertension, number of hypertensive drugs, we will perform a propensity score matched analysis which will be performed in 1 : 3 fashion.
Potential significance Despite the promising results of RDN in regard to several clinically relevant surrogate markers, including blood pressure, there are no outcome data available in the literature. Thus, the findings of this study may provide novel insights into the clinical effects of renal denervation and assess whether the sum of the previously observed beneficial effects may translate into an improved clinical outcome.
- Conditions
- Hypertension, Renal
- Being tested
- Renal denervation
- Medical subject headings
- Hypertension, Renal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
Catheter-based inhibition of renal sympathetic nerve traffic.
| Study group | Role | What they receive |
|---|---|---|
| Treatment resistent hypertensives, treated with renal denervation | Patients having undergone renal denervation and fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years. Receives: Device: Renal denervation | |
| Treatment resistent hypertensives, conservatively treated | Patients fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death
Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death
Measured: From inclusion into the registry and 6 years forward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, RenalStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bert Andersson, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722159
- Sponsor's protocol ID
- ERP-2018-11640
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Patients With Resistant Hypertension Undergoing Renal Denervation: A Report From the Swedish Registry for Renal Denervation
- ClinicalTrials.gov ID
- NCT04722159
- Acronym / sponsor ID
- ERP-2018-11640
- Conditions
- Hypertension, Renal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- 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.
Studies on the impact of RDN on cardiovascular surrogate markers have shown a variety of beneficial effects: RDN is associated with a decrease blood pressure (BP), left ventricular mass (LVM), a reduction in aortic pulse-wave velocity and BP variability as well as an increase in heart rate-recovery. Several of these aspects have been observed independently of office BP response, and might be mediated by a direct modulation of the sympathetic nervous system. Moreover, several independent real - world registries have shown an association of renal denervation and sustained blood pressure reductions of clinically relevant magnitude up to 36 months of follow - up.
Whether the sum of these effects may translate into an improvement of clinical outcomes remains unclear and constitutes the primary subject of proposed registry based study.
Detailed description
Two registries interlinked by the Swedish personal identification number The Swedish Registry for Renal Denervation: The Swedish Registry for Renal Denervation is an investigator - initiated academic online database, developed by our group and supported by the Swedish authorities. The registry contains 130 variables summarizing baseline patient characteristics, procedural details, as well as follow - up data. The database contains patient data from the seven Swedish university hospitals that have performed RDN since 2011 exclusively, thereby providing a nation-wide data set with a follow-up of up to five years.
The Swedish Primary Care Cardiovascular Database (SPCCD):
SPCCD comprises data from 75 000 patients diagnosed with hypertension collected at primary care centres in the Stockholm and Skaraborg region during the time period 2001-2008. Patient baseline characteristics may be derived from the individual electronic medical records.
Study objectives:
- To describe the incidence of the composite end-point of myocardial infarction, stroke, heart failure and cardiovascular death in patients with resistant hypertension treated with RDN as compared to conservatively treated resistant hypertensives.
- Our hypothesis is that RDN treated individuals will show a lower event rate in regard to the composite clinical end - point during the first 5 years of follow - up when compared to conservatively treated individuals with resistant hypertension.
Inclusion criteria:
- Patients fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period period of at least 5 years (SPCCD).
Methods and statistical analysis:
The primary end point of this study is the composite of myocardial infarction, stroke, heart failure and cardiovascular death in patients with resistant hypertension having undergone renal denervation (n = 300), compared to a control group of conservatively treated resistant hypertensives from the SPCCD. The necessary information about the diagnose codes for the events relevant for the primary end - point is made possible through the unique Swedish personal identification number and available through the Swedish population based registries for both the case - and control - group.
In order to adjust for differences in the baseline variables age, sex, diabetes, coronary artery disease, heart failure, baseline blood pressure, duration of hypertension, number of hypertensive drugs, we will perform a propensity score matched analysis which will be performed in 1 : 3 fashion.
Potential significance Despite the promising results of RDN in regard to several clinically relevant surrogate markers, including blood pressure, there are no outcome data available in the literature. Thus, the findings of this study may provide novel insights into the clinical effects of renal denervation and assess whether the sum of the previously observed beneficial effects may translate into an improved clinical outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment resistent hypertensives, treated with renal denervation | – | Device: Renal denervationPatients having undergone renal denervation and fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years. |
| Treatment resistent hypertensives, conservatively treated | – | –Patients fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with resistant hypertension, registered in either the The Swedish Registry for Renal Denervation or the Swedish Primary Care Cardiovascular Database (SPCCD).
Key inclusion criteria (1 listed)
- Patients registered in the Swedish Registry for Renal Denervation or SPCCD, fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP >140/90 despite treatment with at least three antihypertensive drugs).
Key exclusion criteria (1 listed)
- Any patient who has withdrawn consent from being in either registry.
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 denervationCatheter-based inhibition of renal sympathetic nerve traffic. | Device | Treatment resistent hypertensives, treated with renal denervation |
Primary outcome
Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death
Time frame: From inclusion into the registry and 6 years forward
Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Bert Andersson study chair
Sahlgrenska University Hospital
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, Renal, run by Vastra Gotaland Region at 1 site in Sweden.
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 1 inclusion and 1 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 25 Jan 2021. 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 Sweden. 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 Sebastian Völz, PhD (0046 31 3421000, sebastian.volz@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death (time frame: From inclusion into the registry and 6 years forward). 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 25 Jan 2021.