Renal Denervation in Chronic Heart Failure

NCT ID: NCT02146794

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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Renal denervation can be carried out for heart failure

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal denervation

renal denervation

Group Type EXPERIMENTAL

Renal denervation

Intervention Type DEVICE

Renal denervation

Interventions

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Renal denervation

Renal denervation

Intervention Type DEVICE

Other Intervention Names

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Symplicity Renal Denervation System

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darrel P Francis, MD

Role: STUDY_CHAIR

Imperial College London

Justin E Davies, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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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.

Reference Type BACKGROUND
PMID: 24603957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24480181 (View on PubMed)

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.

Reference Type RESULT
PMID: 23031283 (View on PubMed)

Other Identifiers

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ICCH-10/065

Identifier Type: -

Identifier Source: org_study_id

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