Renal Denervation in Chronic Heart Failure

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Device: Renal denervation

• Registration Number: NCT02146794
• Lead Sponsor: Imperial College London

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Study First Posted: 2014-05-26
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	Renal denervation	renal denervation

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 months	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

Name	Time	Method
Systolic blood pressure	6 months	Monitored as inpatient for 5 days, then as outpatient for 6 months
Serum Creatinine	6 months
Serum sodium	6 months
Serum potassium	6 months
6 minute walk distance	6 months