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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
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 19, 2014
    Last Updated
    May 21, 2014
    Sponsor
    Imperial College London
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    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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