Renal Denervation in Chronic Heart Failure

NCT02146794 | Completed Phase 1 DMC

• 1 other identifier: ICCH-10/065
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Renal denervation can be carried out for heart failure

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Systolic blood pressure

  6 months

• Serum Creatinine

  6 months

• Serum sodium

  6 months

• Serum potassium

  6 months

• 6 minute walk distance

  6 months

Other Outcomes (1)

• Left ventricular ejection fraction by Echocardiography

  6 months

Study Arms (1)

Renal denervation

EXPERIMENTAL

renal denervation

Device: Renal denervation

Interventions

Renal denervation DEVICE

Renal denervation

Also known as: Symplicity Renal Denervation System

Renal denervation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Related Publications (3)

• 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.

  PMID: 24603957 BACKGROUND

• 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.

  PMID: 24480181 BACKGROUND

• 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.

  PMID: 23031283 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Darrel P Francis, MD

  Imperial College London

  STUDY CHAIR

• Justin E Davies, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 26, 2014

Record last verified: 2014-05