Hypertension Secondary to Renal DiseaseTreatDialRDNNCT01881035
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
A study testing Renal nerve denervation in people with Hypertension Secondary to Renal Disease, run by Turku University Hospital at 1 site in Finland.
Trial summary
The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Secondary to Renal Disease
- What is being tested?
- Renal nerve denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2013to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with end stage renal disease and drug-resistant blood pressure.
Who cannot join
- pregnancy
- secondary hypertension
- unstable coronary artery disease
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.
Read the detailed description
Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.
- Conditions
- Hypertension Secondary to Renal Disease
- Being tested
- Renal nerve denervation
- Keywords
- Hypertension, End stage renal disease
- Medical subject headings
- Hypertensive Nephropathy, Hypertension, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal nerve denervationProcedure or surgery
Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.
| Study group | Role | What they receive |
|---|---|---|
| Renal nerve denervation | Experimental | Renal nerve denervation Receives: Procedure: Renal nerve denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood pressures before and after intervention
Measured: 2 years
Secondary outcomes (1)
Quality of life
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 posted19 Jun 2013 (estimated)
- Study start1 May 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Recruiting of the whole study population not possible.
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 Hypertension Secondary to Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Oulu University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Principal investigator, Juhani Koistinen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881035
- Sponsor's protocol ID
- VCH Heart Station 10
- Other IDs
- TreatDialRDN (II)
- Acronym
- TreatDialRDN
- Status last verified
- Mar 2021
- First submitted
- 14 Jun 2013
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pietila-Effati PM, Salmela AK, Niemi RT, Ylitalo AS, Koistinen MJ. Renal sympathetic denervation in treating drug-resistant hypertension in a patient on hemodialysis. J Hypertens. 2016 Feb;34(2):368-70. doi: 10.1097/HJH.0000000000000802.
PubMed 26867061
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
- ClinicalTrials.gov ID
- NCT01881035
- Acronym / sponsor ID
- TreatDialRDN / VCH Heart Station 10
- Conditions
- Hypertension Secondary to Renal Disease
- Keywords
- Hypertension, End stage renal disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting of the whole study population not possible.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Oulu University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Jun 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 study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.
Detailed description
Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal nerve denervation | Experimental | Procedure: Renal nerve denervationRenal nerve denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with end stage renal disease and drug-resistant blood pressure.
Key exclusion criteria (3 listed)
- pregnancy
- secondary hypertension
- unstable coronary artery 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 nerve denervationRenal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves. | Procedure or surgery | Renal nerve denervation |
Primary outcome
Comparison of blood pressures before and after intervention
Time frame: 2 years
1 secondary outcome
Quality of life
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruiting of the whole study population not possible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 26867061Pietila-Effati PM, Salmela AK, Niemi RT, Ylitalo AS, Koistinen MJ. Renal sympathetic denervation in treating drug-resistant hypertension in a patient on hemodialysis. J Hypertens. 2016 Feb;34(2):368-70. doi: 10.1097/HJH.0000000000000802.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 nerve denervation in people with Hypertension Secondary to Renal Disease, run by Turku University Hospital 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 1 inclusion and 3 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 10 Mar 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 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?
The study was stopped early (reason given: Recruiting of the whole study population not possible.). 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?
Comparison of blood pressures before and after intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881035, 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 10 Mar 2021.