Clinical Trial: Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Left Cardiac Sympathetic Denervation (LCSD) for Cardiomyopathy Feasibility Pilot Study

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.

Detailed Summary:

STUDY SUMMARY

TITLE Left Cardiac Sympathetic Denervation (LCSD) for Cardiomyopathy Study DESIGN Phase II feasibility parallel randomised controlled trial (RCT) AIMS Assess the feasibility and safety of LCSD in patients with cardiomyopathy and heart failure OUTCOME MEASURES Recruitment rates, retention, follow-up and safety POPULATION 30 patients with heart failure secondary to cardiomyopathy ELIGIBILITY Adult participants with ischemic and non-ischemic cardiomyopathy DURATION 18 months follow up

METHODS:

Participants will be randomized to receive LCSD in addition to optimal medical therapy in the intervention arm (15 patients) and optimal medical therapy in the active control arm (15 patients). Participants would be recruited from both inpatient and outpatient general medical and cardiology wards and clinics at Groote Schuur Hospital where patients with the syndrome of heart failure are frequently referred for subspecialty evaluation and management. Eligible patients who meet the inclusion criteria would be randomized to undergo LCSD in addition to optimal medical therapy (intervention arm) or receive standard optimal medical therapy (active placebo). Optimal therapy for patients with cardiomyopathy and heart failure currently consists of an ace-inhibitor or angiotensinogen receptor blocker, beta-blocker, mineralocorticoid receptor antagonist with or without a loop diuretic, and digoxin. All patients in the study would receive an implantable loop recorder to allow for the accurate determination of episodes of symptomatic and asymptomatic ventricular tachyarrhythmias. In order not to lose all of the clinical outcome information obtained in the pilot phase of the study, we would propose only assessing the pre-specified feasibility and safety aspects of the study and keeping t
Sponsor: University of Cape Town

Current Primary Outcome:

• Feasibility [ Time Frame: 36 months ]
  Recruitment rate
• Feasibility [ Time Frame: 36 months ]
  Patient retention
• Procedure related complications [ Time Frame: 36 months ]
  Measured by:• Horner's syndrome in those under going LCSD • Pneumothorax in those undergoing LCSD • Implantable loop recorder site sepsis

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mortality and morbidity [ Time Frame: 36 months ]
  Measured by: All cause mortality; Heart failure related mortality; Hospital admissions; Ventricular arrhythmias;
• Functional capacity: Measured by 6 minute walk test Quality of life at 6 months Admission to hospital for heart failure Functional Capacity [ Time Frame: 6 monthly for 36 months ]
  Measured by 6 minute walk test
• Functional capacity: Quality of life (EQ-5D questionnaire) Quality of life at 6 months Admission to hospital for heart failure Functional Capacity [ Time Frame: 6 monthly for 36 months ]
  Quality of life (EQ-5D questionnaire)
• End Systolic and Diastolic volumes [ Time Frame: 6 monthly for 36 months ]
  End Systolic and Diastolic volumes as determined by Echocardiography

Original Secondary Outcome: Same as current

Information By: University of Cape Town

Dates:
Date Received: February 24, 2017
Date Started: November 24, 2016
Date Completion: February 2020
Last Updated: March 1, 2017
Last Verified: March 2017