Heart FailureSymplicityHFNCT01392196
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
A study testing Renal Denervation in people with Heart Failure, run by Medtronic Vascular at 1 site in Australia.
Trial summary
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure. 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 Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2011to Jun 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
- Heart Failure patients NYHA Class II or III
- Renal Impairment Left Ventricular Ejection Function <40%
- GFR 30 to 75 mL/min/1.73m2
- Optimal stable medical therapy
Who cannot join
- Renal artery anatomy must be eligible for treatment as determined by Angiography, and
- History of prior renal artery intervention
- Single functioning kidney.
- Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
- Systolic BP < 90 mmHG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.
- Conditions
- Heart Failure
- Being tested
- Renal Denervation
- Keywords
- Renal Impairment
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Renal Denervation using the Symplicity Catheter in Heart Failure Population
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Renal Denervation Receives: Procedure: Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Measured: 6 month
Secondary outcomes (2)
Ventricular function as measured by Echocardiography
Measured: 6 month
Renal function as measured by Glomerular Filtration Rate (GFR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2016
Why it stopped: No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed
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.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Krum, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392196
- Sponsor's protocol ID
- TP085
- Acronym
- SymplicityHF
- Status last verified
- Jan 2017
- First submitted
- 7 Jul 2011
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
- ClinicalTrials.gov ID
- NCT01392196
- Acronym / sponsor ID
- SymplicityHF / TP085
- Conditions
- Heart Failure
- Keywords
- Renal Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Jul 2011 (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.
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Procedure: Renal DenervationRenal Denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart Failure patients NYHA Class II or III
- Renal Impairment Left Ventricular Ejection Function <40%
- GFR 30 to 75 mL/min/1.73m2
- Optimal stable medical therapy
Key exclusion criteria (5 listed)
- Renal artery anatomy must be eligible for treatment as determined by Angiography, and
- History of prior renal artery intervention
- Single functioning kidney.
- Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
- Systolic BP < 90 mmHG
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 DenervationRenal Denervation using the Symplicity Catheter in Heart Failure Population | Procedure or surgery | Single arm |
Primary outcome
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Time frame: 6 month
2 secondary outcomes
Ventricular function as measured by Echocardiography
Time frame: 6 month
Renal function as measured by Glomerular Filtration Rate (GFR)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Henry Krum, MD principal investigator
The Alfred
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 Heart Failure, run by Medtronic Vascular at 1 site in Australia.
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 4 inclusion and 5 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 2017. 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 Australia. 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: No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed). 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?
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events (time frame: 6 month). 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 2017.