Cardiac FailurePhase 2RDT-PEFNCT01840059
Renal Denervation in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Renal sympathetic denervation in people with Cardiac Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Failure
- What is being tested?
- Renal sympathetic denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Sep 2015
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EF>40%
- NHYA 2-3
- Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)
Who cannot join
- Previously documented EF<40%
- Hypertrophic, restrictive, dilated cardiomyopathy
- Significant valvular heart disease
- Unfavourable renal artery anatomy for renal denervation
- eGFR<45
- Contraindication to MRI
- Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.
The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).
Read the detailed description
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.
- Conditions
- Cardiac Failure
- Being tested
- Renal sympathetic denervation
- Keywords
- Cardiac Failure, Autonomic 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 sympathetic denervationDevice
Also called Medtronic Symplicity Catheter
A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Experimental | Renal denervation using the Medtronic Symplicity catheter. Receives: Device: Renal sympathetic denervation |
| Control | No intervention | HF-PEF patients who will serve as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptoms
Minnesota Living with Heart Failure Questionnaire
Measured: 12 months
Change in Exercise Function
Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing
Measured: 12 months
Change in Heart Failure Biomarker
BNP (Natriuretic peptide)
Measured: 12 months
Change in LV (Left Ventricle) filling pressure
E/E' on echocardiography
Measured: 12 months
Change in LV remodelling
LV mass index
Measured: 12 months
Change in Left atrial (LA) size
LA volume index
Measured: 12 months
Secondary outcomes (8)
Change in Autonomic function
Heart rate variability
Measured: 3 and 12 months
Change in Renal function
Urea and Creatinine
Measured: 3 and 12 months
Change in Vascular function
Aorta MRI (Magnetic Resonance Imaging)
Measured: 3 and 12 months
Change in Autonomic function
mIBG radiotracer assessment
Measured: 3 and 12 months
Change in neurohormones
Neurohormones
Measured: 3 and 12 months
Change in renal blood flow
Renal MRI
Measured: 3 and 12 months
Change in Blood pressure
ABPM (Ambulatory Blood Pressure Monitoring)
Measured: 3 and 12 months
Change in Endothelial function
EndoPat
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
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 Cardiac 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo di Mario, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840059
- Sponsor's protocol ID
- 2012HS001B
- Acronym
- RDT-PEF
- Status last verified
- Sep 2015
- First submitted
- 17 Apr 2013
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x.
PubMed 22392370
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.
- ClinicalTrials.gov ID
- NCT01840059
- Acronym / sponsor ID
- RDT-PEF / 2012HS001B
- Conditions
- Cardiac Failure
- Keywords
- Cardiac Failure, Autonomic Denervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Apr 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 purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).
Detailed description
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Experimental | Device: Renal sympathetic denervationRenal denervation using the Medtronic Symplicity catheter. |
| Control | No intervention | –HF-PEF patients who will serve as control. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- EF>40%
- NHYA 2-3
- Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)
Key exclusion criteria (7 listed)
- Previously documented EF<40%
- Hypertrophic, restrictive, dilated cardiomyopathy
- Significant valvular heart disease
- Unfavourable renal artery anatomy for renal denervation
- eGFR<45
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 sympathetic denervationAlso: Medtronic Symplicity CatheterA fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia | Device | Renal sympathetic denervation |
Primary outcome
Change in Symptoms
Time frame: 12 months
Minnesota Living with Heart Failure Questionnaire
Change in Exercise Function
Time frame: 12 months
Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing
Change in Heart Failure Biomarker
Time frame: 12 months
BNP (Natriuretic peptide)
Change in LV (Left Ventricle) filling pressure
Time frame: 12 months
E/E' on echocardiography
Change in LV remodelling
Time frame: 12 months
LV mass index
Change in Left atrial (LA) size
Time frame: 12 months
LA volume index
8 secondary outcomes
Change in Autonomic function
Time frame: 3 and 12 months
Change in Renal function
Time frame: 3 and 12 months
Change in Vascular function
Time frame: 3 and 12 months
Change in Autonomic function
Time frame: 3 and 12 months
Change in neurohormones
Time frame: 3 and 12 months
Change in renal blood flow
Time frame: 3 and 12 months
Change in Blood pressure
Time frame: 3 and 12 months
Change in Endothelial function
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Background: PubMed 22392370Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x.
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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.
Carlo di Mario principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal sympathetic denervation in people with Cardiac Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 15 Sep 2015. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Symptoms (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT01840059, 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 15 Sep 2015.