Renal Denervation in Chronic Heart Failure

Heart Failure Clinical Trial

— REACH  

Official title:

Renal Denervation in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146794
• Other study ID #: ICCH-10/065
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2014
• Last updated: May 21, 2014
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Renal denervation can be carried out for heart failure

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Renal denervation
Renal denervation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

References & Publications (3)

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 — View Citation

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. Review. — View Citation

Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. Erratum in: BMJ. 2014;348:g2088. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left ventricular ejection fraction by Echocardiography		6 months	No
Primary	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	Yes
Secondary	Systolic blood pressure	Monitored as inpatient for 5 days, then as outpatient for 6 months	6 months	Yes
Secondary	Serum Creatinine		6 months	Yes
Secondary	Serum sodium		6 months	Yes
Secondary	Serum potassium		6 months	Yes
Secondary	6 minute walk distance		6 months	Yes