Renal Artery Denervation in Chronic Heart Failure Study
NCT ID: NCT01639378
Last Updated: 2016-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
76 participants
INTERVENTIONAL
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.
Primary Purpose: Treatment
Chronic Systolic Heart Failure
Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
-Intervention: Device: Renal denervation (Symplicity Catheter System)
Patients are randomised in the cath lab to receive either renal denervation or sham procedure.
Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)
In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
Renal Denervation
Symplicity Catheter System
Control group
Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Renal Denervation
Symplicity Catheter System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* New York Heart Association class II or higher
* Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
* Ejection fraction less than 40%
Exclusion Criteria
* Unfavourable renal anatomy (renal artery stenosis)
* Unable to walk on a treadmill for cardiopulmonary exercise test
* Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
* Severe lung disease
* Symptomatic orthostatic dizziness
* Unable to consent
* Pregnancy
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darrel P Francis, BA, MD
Role: STUDY_DIRECTOR
Imperial College London
Justin E Davies, MBBS, PHD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REACH
Identifier Type: -
Identifier Source: org_study_id