Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study

NCT03071653 | Suspended Phase 2

• 1 other identifier: 001001001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiomyopathy; Left Cardiac Sympathetic Denervation

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruiting

  Recruitment rate

  36 months

• Feasibility of performing the procedure in recruited patients

  Patient retention

  36 months

• Procedure related complications

  Measured by:• Horner's syndrome in those under going LCSD • Pneumothorax in those undergoing LCSD • Implantable loop recorder site sepsis

  36 months

Secondary Outcomes (4)

• Mortality and morbidity

  36 months

• Functional capacity: Measured by 6 minute walk test Quality of life at 6 months Admission to hospital for heart failure Functional Capacity

  6 monthly for 36 months

• Functional capacity: Quality of life (EQ-5D questionnaire) Quality of life at 6 months Admission to hospital for heart failure Functional Capacity

  6 monthly for 36 months

• End Systolic and Diastolic volumes

  6 monthly for 36 months

Study Arms (2)

Left Cardiac Sympathetic Denervation (LCSD)

ACTIVE COMPARATOR

Left Cardiac Sympathetic Denervation (LCSD) in addition to Optimal Medical Therapy (OMT)

Procedure: Left Cardiac Sympathetic Denervation (LCSD); Other: Optimal Medical Therapy

OMT only

OTHER

Optimal Medical Therapy (OMT) only

Other: Optimal Medical Therapy

Interventions

Left Cardiac Sympathetic Denervation (LCSD) PROCEDURE

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

Left Cardiac Sympathetic Denervation (LCSD)

Optimal Medical Therapy OTHER

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

Left Cardiac Sympathetic Denervation (LCSD); OMT only

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• New York Heart Association (NYHA) II/III stable heart failure due to an ischemic or non-ischemic cardiomyopathy with a Left Ventricular Ejection Fraction \<=35% based on Echocardiogram, ERNA or MRI performed in the last 12 months. For the purpose of this study, Ischemic cardiomyopathy will be defined as Left Ventricular systolic dysfunction (Ejection Fraction \<35%) associated with 75% narrowing of at least 1 of the 3 major coronary arteries, a documented history of a ST elevation myocardial infarction or significant regional wall motion abnormality on an echocardiogram. Non-ischemic cardiomyopathy will be defined as Left Ventricular systolic dysfunction \<35% in the absence of known coronary artery disease or regional wall motion abnormality on echocardiography.
• No history of a prior cardiac arrest or sustained (\>30 seconds or \<30s if haemodynamically unstable) ventricular tachyarrhythmia.
• Signed informed consent forms will be available in IsiXhosa, Afrikaans and English.

You may not qualify if:

• History of prior unexplained syncope, sudden cardiac arrest or ventricular arrhythmia
• Peripartum cardiomyopathy or cardiomyopathy associated with thyrotoxicosis
• History of coronary revascularization or percutaneous intervention in the preceding 3 months
• Myocardial infarction in the preceding 1 month
• NYHA IV at enrollment
• Patient taking an antiarrhythmic drug (not including beta-blockers)
• Pregnancy
• Any non-cardiac condition that is associated with a high likelihood of death during the trial such as major organ dysfunction or malignancy.

Sponsors & Collaborators

• University of Cape Town: lead
• Medtronic: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 7, 2017
• Study Start: November 24, 2016
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

ZA (1)