Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study (LCSD)
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ClinicalTrials.gov Identifier: NCT03071653 |
Recruitment Status : Unknown
Verified March 2017 by Mpiko Ntsekhe, University of Cape Town.
Recruitment status was: Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Dilated Cardiomyopathy Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy | Procedure: Left Cardiac Sympathetic Denervation (LCSD) Other: Optimal Medical Therapy | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised Control Trial |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Left Cardiac Sympathetic Denervation (LCSD) for Cardiomyopathy Feasibility Pilot Study |
Actual Study Start Date : | November 24, 2016 |
Estimated Primary Completion Date : | November 2019 |
Estimated Study Completion Date : | February 2020 |

Arm | Intervention/treatment |
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Active Comparator: Left Cardiac Sympathetic Denervation (LCSD)
Left Cardiac Sympathetic Denervation (LCSD) in addition to Optimal Medical Therapy (OMT)
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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:
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OMT only
Optimal Medical Therapy (OMT) only
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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:
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- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071653
Contact: Constance Philander | +27214046136 | connie.talliard@uct.ac.za | |
Contact: Noloyiso Mtana | +27214046086 | nolly.mtana@uct.ac.za |
South Africa | |
University of Cape Town | Recruiting |
Cape Town, Western Cape, South Africa, 7925 | |
Contact: Constance Philander +27214046136 connie.talliard@uct.ac.za | |
Contact: Noloyiso Mtana +27214046086 nolly.mtana@uct.ac.za | |
Principal Investigator: Mpiko Ntsekhe | |
Principal Investigator: Ashley Chin | |
Sub-Investigator: Charle Viljoen | |
Sub-Investigator: Peter Schwartz | |
Sub-Investigator: Jacques Roussouw | |
Sub-Investigator: Tim Pennel | |
Sub-Investigator: Jacques Sherman |
Responsible Party: | Mpiko Ntsekhe, Professor, University of Cape Town |
ClinicalTrials.gov Identifier: | NCT03071653 |
Other Study ID Numbers: |
001001001 |
First Posted: | March 7, 2017 Key Record Dates |
Last Update Posted: | March 7, 2017 |
Last Verified: | March 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiomyopathy Left Cardiac Sympathetic Denervation |
Cardiomyopathies Cardiomyopathy, Dilated Heart Diseases Cardiovascular Diseases Cardiomegaly |