Renal Denervation in Chronic Heart Failure (REACH)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Renal denervation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renal denervation
Arm Description
renal denervation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Systolic blood pressure
Monitored as inpatient for 5 days, then as outpatient for 6 months
Serum Creatinine
Serum sodium
Serum potassium
6 minute walk distance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02146794
Brief Title
Renal Denervation in Chronic Heart Failure
Acronym
REACH
Official Title
Renal Denervation in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Renal denervation can be carried out for heart failure
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
renal denervation
Intervention Type
Device
Intervention Name(s)
Renal denervation
Other Intervention Name(s)
Symplicity Renal Denervation System
Intervention Description
Renal denervation
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Monitored as inpatient for 5 days, then as outpatient for 6 months
Time Frame
6 months
Title
Serum Creatinine
Time Frame
6 months
Title
Serum sodium
Time Frame
6 months
Title
Serum potassium
Time Frame
6 months
Title
6 minute walk distance
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Left ventricular ejection fraction by Echocardiography
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MD
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Justin E Davies, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24603957
Citation
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.
Results Reference
background
PubMed Identifier
24480181
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.
Results Reference
background
PubMed Identifier
23031283
Citation
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.
Results Reference
result
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Renal Denervation in Chronic Heart Failure
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