Renal Artery Denervation in Chronic Heart Failure Study

Chronic Systolic Heart Failure Clinical Trial

— REACH  

Official title:

Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01639378
• Other study ID #: REACH
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 10, 2012
• Last updated: November 10, 2016
• Start date: August 2012

Study information

• Verified date: August 2016
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial Summary

The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.

Description:

Interventional study

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Chronic heart failure due to systolic dysfunction

• 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:

• Estimated GFR<35ml/hr

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Systolic Heart Failure
• Heart Failure
• Heart Failure, Systolic

Intervention

Procedure:
• Renal Denervation
Symplicity Catheter System

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Sobotka PA, Krum H, Böhm 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in symptomatology	Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire	Baseline to 12 months post-randomization	No
Secondary	Improvement in peak VO2 on cardiopulmonary exercise testing	The peak VO2 will be compared in the interventional against the sham arm	Baseline to 12 months post-randomization	No
Secondary	Improvement in self-paced exercise distance	Improvement in 6 min walk to in interventional arm compared to sham arm	Baseline to 12 months post-randomization	No
Secondary	Change in chemoreflex sensitivity	Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm	Baseline to 12 months post-randomization	No
Secondary	Change in NYHA functional classification	Assess the change in NYHA in interventional arm in comparison to sham arm	Baseline to 12 months post-randomization	No
Secondary	Incidence of Major Adverse Events	The incidence of major adverse events will be compared in the interventional against the sham arm	Baseline to 12 months post-randomization	Yes