Renal Denervation in Chronic Heart Failure (REACH)

Renal denervation can be carried out for heart failure

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Renal denervation

Detailed Description

There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.

This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.

Exclusion Criteria:

• Clinically unstable patients or those with significant valvular disease
• An estimated glomerular filtration rate <35 ml/min
• Unfavourable renal anatomy
• Tortuous femoral arteries were not eligible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal denervation; renal denervation	Device: Renal denervation; Renal denervation; Other Names: Symplicity Renal Denervation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure. A deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine		6 months
Systolic blood pressure	Monitored as inpatient for 5 days, then as outpatient for 6 months	6 months
Serum sodium		6 months
Serum potassium		6 months
6 minute walk distance		6 months

Other Outcome Measures

Outcome Measure	Time Frame
Left ventricular ejection fraction by Echocardiography	6 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Study Chair: Darrel P Francis, MD, Imperial College London; Principal Investigator: Justin E Davies, MD, Imperial College London

Publications and helpful links

General Publications

• Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available. Erratum In: BMJ. 2014;348:g2088.
• Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.
• Davies JE, Manisty CH, Petraco R, Barron AJ, Unsworth B, Mayet J, Hamady M, Hughes AD, Sever PS, Sobotka PA, Francis DP. First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study. Int J Cardiol. 2013 Jan 20;162(3):189-92. doi: 10.1016/j.ijcard.2012.09.019. Epub 2012 Sep 29.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ICCH-10/065