Heart FailureHeart-RNDNCT02638324
Supportive Treatment of Severe Heart Failure by Renal Denervation
A study testing Renal nervous denervation in people with Heart Failure, run by Turku University Hospital at 1 site in Finland.
Trial summary
The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Renal nervous denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2014to 30 Jan 2019
- 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
- NYHA III-IV
- ejection fraction <45 %
- 6-minute walking test under 440m
Who cannot join
- Unstable hemodynamic state
- uncooperation
Trial locations and contacts
1 site in 1 country.
About this study
The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.
Read the detailed description
The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.
- Conditions
- Heart Failure
- Being tested
- Renal nervous denervation
- Keywords
- Renal nervous denervation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal nervous denervationProcedure or surgery
The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.
| Study group | Role | What they receive |
|---|---|---|
| Renal nervous denervation. | Active comparator | Renal nervous denervation is performed to the patients who do not response properly to conventional therapy. The patients are randomised according to the waiting list principle. Receives: Procedure: Renal nervous denervation |
| Renal nervous denervation (delayed) | Active comparator | Renal nervous denervation is performed after six months on the waiting list Receives: Procedure: Renal nervous denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test
Composite outcome measure
Measured: 24 months
Secondary outcomes (3)
Patient history
Composite outcome measure
Measured: 24 months
Cardiac echocardiography
Composite outcome measure
Measured: 24 months
P-proBNP
Composite outcome measure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study start1 Dec 2014
- Primary completion31 Dec 2018
- Study completion30 Jan 2019
Why it stopped: Because of the lack of the candidates and because of restrictions of denervation at the completion date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Satakunta Central Hospital
- Responsible party
- Sponsor
- Investigators
- Mari-Anne Vaittinen, MD, Study chair, Vaasa Central HospitlaMari-Anne Vaittinen, MD, Study chair, Vaasa Central Hospital, Vaasa, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638324
- Sponsor's protocol ID
- Juhani02
- Acronym
- Heart-RND
- Status last verified
- Mar 2021
- First submitted
- 20 May 2015
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Treatment of Severe Heart Failure by Renal Denervation
- ClinicalTrials.gov ID
- NCT02638324
- Acronym / sponsor ID
- Heart-RND / Juhani02
- Conditions
- Heart Failure
- Keywords
- Renal nervous denervation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the lack of the candidates and because of restrictions of denervation at the completion date.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Satakunta Central Hospital
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 23 Dec 2015 (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 overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.
Detailed description
The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal nervous denervation. | Active comparator | Procedure: Renal nervous denervationRenal nervous denervation is performed to the patients who do not response properly to conventional therapy. The patients are randomised according to the waiting list principle. |
| Renal nervous denervation (delayed) | Active comparator | Procedure: Renal nervous denervationRenal nervous denervation is performed after six months on the waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA III-IV
- ejection fraction <45 %
- 6-minute walking test under 440m
Key exclusion criteria (2 listed)
- Unstable hemodynamic state
- uncooperation
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 nervous denervationThe heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy. | Procedure or surgery | Renal nervous denervation (delayed), Renal nervous denervation. |
Primary outcome
6-minute walking test
Time frame: 24 months
Composite outcome measure
3 secondary outcomes
Patient history
Time frame: 24 months
Cardiac echocardiography
Time frame: 24 months
P-proBNP
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Because of the lack of the candidates and because of restrictions of denervation at the completion date.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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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.
Mari-Anne Vaittinen, MD study chair
Vaasa Central Hospitla
Mari-Anne Vaittinen, MD study chair
Vaasa Central Hospital, Vaasa, Finland
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 nervous denervation in people with Heart Failure, 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 3 inclusion and 2 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 12 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: Because of the lack of the candidates and because of restrictions of denervation at the completion date.). 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?
6-minute walking test (time frame: 24 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 12 Mar 2021.