Dilated CardiomyopathyPhase 2LCSDNCT03071653
Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study
A Phase 2 study testing Left Cardiac Sympathetic Denervation (LCSD) and Optimal Medical Therapy in people with Dilated Cardiomyopathy and Ischemic Cardiomyopathy, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy
- What is being tested?
- Left Cardiac Sympathetic Denervation (LCSD) and Optimal Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Nov 2016to Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Cardiac Sympathetic Denervation (LCSD) for Cardiomyopathy Feasibility Pilot Study
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.
Read the detailed description
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 the data on efficacy outcomes blinded for inclusion in the fully powered main study.
The 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 (3). LCSD raises the ventricular fibrillation threshold without impairing cardiac contractility or reducing heart rate. LCSD results in pre-ganglionic denervation, thus preventing re-innervation and producing permanent antifibrillatory effects. This procedure can be performed by video-assisted thoracoscopic surgery (VATS) usually in less than 45 minutes and will be conducted by thoracic surgeons at Groote Schuur Hospital. The lead thoracic surgeon (J.R.) has a large experience in performing this procedure for the indication of hyperhidrosis in over 200 patients (personal communication). This experienced thoracic surgeon will lead a team of thoracic surgeons (T.P., L.M.) to perform the procedure.
Implantable loop recorder (ILR) insertion The implantable loop recorder is a small device that will be inserted at the end of the LCSD procedure by the thoracic surgeon or after enrolment in the optimal medical therapy arm by a cardiologist. This loop recorder is inserted under sterile conditions in the catheter laboratory or operating theatre. In the catheter laboratory, the device is inserted under local anaesthetic, subcutaneously over the left precordium and usually takes less than 15 minutes. The implantable loop recorder is a well-established device to quantify and detect atrial and ventricular tachyarrhythmias with an excellent safety record. The device has a battery life of up to 3 years and can be removed via a small skin incision at the end of the study. Implantable loop recorder insertion does not carry risk of known major complications. There is a minimal risk (<1%) of complications (infection, bleeding) as the device is implanted subcutaneously. Potential complications include superficial skin infections that readily responds to antibiotics. Device removal is easy to perform and is seldom required.
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:
- A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent)
- A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent)
- A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent)
- The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician
- Being tested
- Left Cardiac Sympathetic Denervation (LCSD), Optimal Medical Therapy
- Keywords
- Cardiomyopathy, Left Cardiac Sympathetic Denervation
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Cardiac Sympathetic Denervation (LCSD)Procedure or surgery
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
Optimal Medical TherapyOther
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:
- A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent)
- A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent)
- A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent)
- The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician
| Study group | Role | What they receive |
|---|---|---|
| Left Cardiac Sympathetic Denervation (LCSD) | Active comparator | Left Cardiac Sympathetic Denervation (LCSD) in addition to Optimal Medical Therapy (OMT) Receives: Procedure: Left Cardiac Sympathetic Denervation (LCSD); Other: Optimal Medical Therapy |
| OMT only | Other | Optimal Medical Therapy (OMT) only Receives: Other: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting
Recruitment rate
Measured: 36 months
Feasibility of performing the procedure in recruited patients
Patient retention
Measured: 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
Measured: 36 months
Secondary outcomes (4)
Mortality and morbidity
Measured by: All cause mortality; Heart failure related mortality; Hospital admissions; Ventricular arrhythmias;
Measured: 36 months
Functional capacity: Measured by 6 minute walk test Quality of life at 6 months Admission to hospital for heart failure Functional Capacity
Measured by 6 minute walk test
Measured: 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
Quality of life (EQ-5D questionnaire)
Measured: 6 monthly for 36 months
End Systolic and Diastolic volumes
End Systolic and Diastolic volumes as determined by Echocardiography
Measured: 6 monthly for 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start24 Nov 2016
- Primary completionNov 2021 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: COVID and Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Mpiko Ntsekhe, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071653
- Sponsor's protocol ID
- 001001001
- Acronym
- LCSD
- Status last verified
- May 2021
- First submitted
- 24 Feb 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Cardiac Sympathetic Denervation (LCSD) for Cardiomyopathy Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT03071653
- Acronym / sponsor ID
- LCSD / 001001001
- Keywords
- Cardiomyopathy, Left Cardiac Sympathetic Denervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID and Funding
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 the data on efficacy outcomes blinded for inclusion in the fully powered main study.
The 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 (3). LCSD raises the ventricular fibrillation threshold without impairing cardiac contractility or reducing heart rate. LCSD results in pre-ganglionic denervation, thus preventing re-innervation and producing permanent antifibrillatory effects. This procedure can be performed by video-assisted thoracoscopic surgery (VATS) usually in less than 45 minutes and will be conducted by thoracic surgeons at Groote Schuur Hospital. The lead thoracic surgeon (J.R.) has a large experience in performing this procedure for the indication of hyperhidrosis in over 200 patients (personal communication). This experienced thoracic surgeon will lead a team of thoracic surgeons (T.P., L.M.) to perform the procedure.
Implantable loop recorder (ILR) insertion The implantable loop recorder is a small device that will be inserted at the end of the LCSD procedure by the thoracic surgeon or after enrolment in the optimal medical therapy arm by a cardiologist. This loop recorder is inserted under sterile conditions in the catheter laboratory or operating theatre. In the catheter laboratory, the device is inserted under local anaesthetic, subcutaneously over the left precordium and usually takes less than 15 minutes. The implantable loop recorder is a well-established device to quantify and detect atrial and ventricular tachyarrhythmias with an excellent safety record. The device has a battery life of up to 3 years and can be removed via a small skin incision at the end of the study. Implantable loop recorder insertion does not carry risk of known major complications. There is a minimal risk (<1%) of complications (infection, bleeding) as the device is implanted subcutaneously. Potential complications include superficial skin infections that readily responds to antibiotics. Device removal is easy to perform and is seldom required.
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:
- A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent)
- A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent)
- A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent)
- The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Left Cardiac Sympathetic Denervation (LCSD) | Active comparator | Procedure: Left Cardiac Sympathetic Denervation (LCSD), Other: Optimal Medical TherapyLeft Cardiac Sympathetic Denervation (LCSD) in addition to Optimal Medical Therapy (OMT) |
| OMT only | Other | Other: Optimal Medical TherapyOptimal Medical Therapy (OMT) only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Left Cardiac Sympathetic Denervation (LCSD) |
| Optimal Medical TherapyAll 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 | Other | Left Cardiac Sympathetic Denervation (LCSD), OMT only |
Primary outcome
Feasibility of recruiting
Time frame: 36 months
Recruitment rate
Feasibility of performing the procedure in recruited patients
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
4 secondary outcomes
Mortality and morbidity
Time frame: 36 months
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
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
End Systolic and Diastolic volumes
Time frame: 6 monthly for 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Left Cardiac Sympathetic Denervation (LCSD) and Optimal Medical Therapy in people with Dilated Cardiomyopathy and Ischemic Cardiomyopathy, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.