- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879670
Partial Left Ventricular Support in Advanced Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The CircuLite Synergy pump is a new minimally-invasive partial support left ventricular assist device (LVAD) that pumps blood from the left atrium to the right subclavian artery. Ex vivo pilot data suggests that the Synergy pump induces structural reverse remodelling, which proposes the Synergy device as a new disease-modifying therapy. We will assess whether the Synergy pump facilitates functional, structural and molecular LV reverse remodelling in vivo; assess how this can be determined and predicted by analysis of circulating micro RNA profiles and specific echocardiographic parameters; and evaluate the haematological abnormalities associated with this new LVAD.
We will address these questions with a prospective, observational study comparing patients implanted with the Synergy device with matched heart failure controls. The two study centres will be Royal Brompton & Harefield NHS Foundation Trust (Harefield Hospital) and University Hospitals Leuven, Belgium. We will recruit a total of 64 patients. The primary outcome will be change in peak VO2 at 6 months. Secondary outcomes will include functional parameters, profiling of circulating microRNA, multimodal echocardiographic assessment and comprehensive assessment of platelet activation and coagulopathy.
We will quantify the LV reverse remodelling associated with partial support; define new echo and microRNA markers of reverse remodelling for clinical use, with insights into underlying pathophysiology; and describe the haematological profile of these patients to guide future antiplatelet and anticoagulant therapy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium
- Universitaire Ziekenhuizen Leuven
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London, United Kingdom, SW3 6NP
- Royal Brompton & Harefield NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with ischaemic or dilated cardiomyopathy aged 18 to 80 years.
- Symptoms categorised by INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) at level 3-6 despite optimal tolerated medical therapy. Practically this includes patients who are in hospital or managing at home with substantial dependence on hospital care.
- Peak VO2 <15ml/kg/min with respiratory exchange ratio>1 on cardiopulmonary exercise testing OR a 6-minute walking distance <300m OR inability to perform an exercise test due to the severity of heart failure.
- Informed consent obtained prior to entering the study.
Exclusion Criteria:
- Cause of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or active myocarditis
- Body surface area <1.2M2 or >2.3M2, or body mass index >32 kg/M2.
- Severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume in 1 second <50% of predicted.
- History of pulmonary hypertension with maintained pulmonary vascular resistance measured > 4 Wood units or transpulmonary gradient >14mmHg.
- Pregnancy.
- Evidence of intrinsic hepatic disease defined as liver enzyme levels > 5 times the upper limit of normal within 4 days before enrolment, severe liver dysfunction, cirrhosis or portal hypertension.
- Occurrence of stroke within 90 days before enrolment.
- Impairment of cognitive function or presence of any form of irreversible dementia.
- Recent history of psychiatric disease (including severe drug or alcohol abuse) that is likely to impair compliance with the study protocol.
- Platelet count <50 x103mm3 within 24 hours before enrolment.
- Creatinine clearance < 30ml/min.
- High probability of non-compliance.
- The patient is deemed unsuitable by the clinical team for other reasons.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Synergy
Patients in the Synergy group will have severe advanced heart failure (see inclusion criteria) and will have been selected by their clinical team for implantation of a CircuLite Synergy left ventricular assist device.
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Other Names:
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Control
Patients in the Synergy group will have severe advanced heart failure (see inclusion criteria) and will have been selected by their clinical team to continue current optimal medical and device therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in maximal aerobic exercise capacity (peak VO2)
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in 6-minute walk distance
Time Frame: 6 months
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6 months
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Change in New York Heart Association (NYHA) functional class
Time Frame: 6 months
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6 months
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Change in B-type natriuretic peptide
Time Frame: 6 months
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6 months
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Change in ventricular dimensions as measured by echocardiography
Time Frame: 6 months
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6 months
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Change in ventricular strain as measured by echocardiography
Time Frame: 6 months
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6 months
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Change in circulating microRNA expression profile
Time Frame: 6 months
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6 months
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Change in ventilatory equivalent for carbon dioxide (VE/VCO2) slope
Time Frame: 6 months
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6 months
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Change in haemodynamic parameters at right heart catheterisation
Time Frame: 6 months
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6 months
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Change in quality of life score
Time Frame: 6 months
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6 months
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Accumulated days of hospital inpatient stay due to cardiovascular reasons
Time Frame: 6 months
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6 months
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Incidence of significant haematological derangements
Time Frame: 6 months
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6 months
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Number of participants suffering adverse events
Time Frame: 6 months
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'Adverse events' are defined as major bleeding, thromboembolism, stroke, infection, perioperative complications, right ventricular failure, device-related morbidity and device failure.
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6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: John R Pepper, FRCS, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012HSB002B
- FS/13/34/30173 (Other Grant/Funding Number: British Heart Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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