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Completed

NCT Number: NCT02146794

Renal Denervation in Chronic Heart Failure

Renal denervation can be carried out for heart failure

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Denervation

Device

Renal denervation

Other names: Symplicity Renal Denervation System

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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 outcomes

  1. Systolic blood pressure

    Time frame: 6 months

    Monitored as inpatient for 5 days, then as outpatient for 6 months

  2. Serum Creatinine

    Time frame: 6 months

  3. Serum sodium

    Time frame: 6 months

  4. Serum potassium

    Time frame: 6 months

  5. 6 minute walk distance

    Time frame: 6 months

Other outcomes

  1. Left ventricular ejection fraction by Echocardiography

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: REACH

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 26, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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