Partial Left Ventricular Support in Advanced Heart Failure

NCT01879670 | Terminated

• 2 other identifiers: 2012HSB002BFS/13/34/30173
• Study Type: observational
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Heart-Assist Devices

Outcome Measures

Primary Outcomes (1)

• Change in maximal aerobic exercise capacity (peak VO2)

  6 months

Secondary Outcomes (12)

• Change in 6-minute walk distance

  6 months

• Change in New York Heart Association (NYHA) functional class

  6 months

• Change in B-type natriuretic peptide

  6 months

• Change in ventricular dimensions as measured by echocardiography

  6 months

• Change in ventricular strain as measured by echocardiography

  6 months

Study Arms (2)

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.

Device: CircuLite Synergy left ventricular assist device

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.

Interventions

CircuLite Synergy left ventricular assist device DEVICE

Also known as: CircuLite Synergy circulatory assist device, SIK 100

Synergy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be selected from advanced heart failure clinics at two tertiary heart hospitals with large cardiac transplantation and mechanical circulatory support programmes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (2)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Links

• Royal Brompton \& Harefield NHS Foundation Trust
• Universitaire Ziekenhuizen Leuven

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• John R Pepper, FRCS

  Royal Brompton & Harefield NHS Foundation Trust and Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

BE (1); GB (1)