Heart Failure Clinical Trial
Official title:
Partial Left Ventricular Support in Advanced Heart Failure
Heart failure is a common condition, and the number of people with advanced disease continues to increase. We need new treatments that improve patients' symptoms and extend life. Recently the new CircuLite Synergy pump has come into use. It is the smallest pump manufactured to date and does not cover the full work of the heart, instead providing "partial" support. One interesting thing about this is that taking some strain off the heart might allow the muscle to repair and rebuild its own strength. This process is called reverse remodelling, and is the topic of this research. Our hypothesis is that "partial" support improves patients' symptoms and causes improvement in heart muscle function. We also want to examine the best techniques for assessing this, including new scanning and molecular tests, and study some practical aspects of the pump to do with blood clotting.
Status | Terminated |
Enrollment | 2 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Universitaire Ziekenhuizen Leuven | Leuven | |
United Kingdom | Royal Brompton & Harefield NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Brompton & Harefield NHS Foundation Trust | Universitaire Ziekenhuizen Leuven |
Belgium, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in maximal aerobic exercise capacity (peak VO2) | 6 months | No | |
Secondary | Change in 6-minute walk distance | 6 months | No | |
Secondary | Change in New York Heart Association (NYHA) functional class | 6 months | No | |
Secondary | Change in B-type natriuretic peptide | 6 months | No | |
Secondary | Change in ventricular dimensions as measured by echocardiography | 6 months | No | |
Secondary | Change in ventricular strain as measured by echocardiography | 6 months | No | |
Secondary | Change in circulating microRNA expression profile | 6 months | No | |
Secondary | Change in ventilatory equivalent for carbon dioxide (VE/VCO2) slope | 6 months | No | |
Secondary | Change in haemodynamic parameters at right heart catheterisation | 6 months | No | |
Secondary | Change in quality of life score | 6 months | No | |
Secondary | Accumulated days of hospital inpatient stay due to cardiovascular reasons | 6 months | No | |
Secondary | Incidence of significant haematological derangements | 6 months | No | |
Secondary | Number of participants suffering adverse events | 'Adverse events' are defined as major bleeding, thromboembolism, stroke, infection, perioperative complications, right ventricular failure, device-related morbidity and device failure. | 6 months | Yes |
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