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Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study

NCT03071653 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-06

No results posted yet for this study

Summary

A randomized controlled trial to test the potential safety and efficacy of LCSD in patients with heart failure due to non-ischemic and ischemic cardiomyopathy at the University of Cape Town. Left Cardiac Sympathetic Denervation (LCSD) is a surgical intervention that modulates the autonomic innervation of the cardiac system. This is important because: a\] sympathetic and parasympathetic tone has a profound effect on the threshold for ventricular tachyarrhythmias-the main cause of sudden cardiac death in this population; and b\] autonomic dysfunction (which is characterized by an imbalance between sympathetic and parasympathetic activation), plays an important detrimental role in the pathophysiology and progression of heart failure.

Conditions

  • Dilated Cardiomyopathy
  • Ischemic Cardiomyopathy
  • Non-ischemic Cardiomyopathy

Interventions

PROCEDURE

Left Cardiac Sympathetic Denervation (LCSD)

The procedure involves the surgical removal of the lower half of the left stellate ganglion (T1) and thoracic ganglia (T2-T4), thereby removing the pro-arrhythmic noradrenergic input to the ventricles

OTHER

Optimal Medical Therapy

All eligible patients with heart failure and depressed left ventricular systolic function will receive guideline and evidence based optimal tolerated medical therapy. The level of risk associated with optimal medical therapy is considered very low. For the majority of patients with heart failure and depressed left ventricular systolic function this will include: 1. A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent) 2. A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent) 3. A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent) 4. The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Cape Town

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-24
Primary Completion
2021-11-30
Completion
2022-02-28

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071653 on ClinicalTrials.gov