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Heart FailureNCT01879670

Partial Left Ventricular Support in Advanced Heart Failure

An observational study of Heart Failure and Heart-Assist Devices, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Heart-Assist Devices
What is being tested?
CircuLite Synergy left ventricular assist device
Type of treatment
Medical device
How many people
2 participants
Where
2 sitesin 2 countries
Study dates
Jun 2013to Jun 2014
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

United Kingdom1 site

  • Royal Brompton & Harefield NHS Foundation Trust

    London, SW3 6NP

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
CircuLite Synergy left ventricular assist device
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CircuLite Synergy left ventricular assist deviceDevice

    Also called CircuLite Synergy circulatory assist device, SIK 100

Study groups in NCT01879670
Study groupRoleWhat they receive
SynergyPatients 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.
Receives: Device: CircuLite Synergy left ventricular assist device
ControlPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in maximal aerobic exercise capacity (peak VO2)

    Measured: 6 months

Secondary outcomes (12)

  1. Change in 6-minute walk distance

    Measured: 6 months

  2. Change in New York Heart Association (NYHA) functional class

    Measured: 6 months

  3. Change in B-type natriuretic peptide

    Measured: 6 months

  4. Change in ventricular dimensions as measured by echocardiography

    Measured: 6 months

  5. Change in ventricular strain as measured by echocardiography

    Measured: 6 months

  6. Change in circulating microRNA expression profile

    Measured: 6 months

  7. Change in ventilatory equivalent for carbon dioxide (VE/VCO2) slope

    Measured: 6 months

  8. Change in haemodynamic parameters at right heart catheterisation

    Measured: 6 months

  9. Change in quality of life score

    Measured: 6 months

  10. Accumulated days of hospital inpatient stay due to cardiovascular reasons

    Measured: 6 months

  11. Incidence of significant haematological derangements

    Measured: 6 months

  12. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Why it stopped: Withdrawal of CircuLite Synergy from clinical use

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01879670
Sponsor's protocol ID
2012HSB002B
Other IDs
FS/13/34/30173
Status last verified
Oct 2015
First submitted
11 Jun 2013
Last updated
28 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Heart-Assist Devices, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in 2 countries.

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 13 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: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, United Kingdom. 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.

Are results available for this study?

The study was stopped early (reason given: Withdrawal of CircuLite Synergy from clinical use). 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?

Change in maximal aerobic exercise capacity (peak VO2) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01879670.

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 28 Oct 2015.

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Clinical Trial NCT01879670 | AzTrials