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Trial record 44 of 157 for:    Idiopathic Dilated Cardiomyopathy

Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM (DCM-Support)

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ClinicalTrials.gov Identifier: NCT03572660
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:
The DCM SUPPORT study is a single centre, single arm study evaluating the change in left ventricular ejection fraction with the combines use of bone marrow derived stem cells and G-CSF with a percutaneous circulatory assistance for the treatment of dilated cardiomyopathy.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Biological: Bone marrow derived mononuclear cells and G-CSF Phase 2

Detailed Description:
The DCM SUPPORT study is a single centre, single arm, phase II pilot study. The primary endpoint will be a change in LVEF from baseline measured by a CT scan of the heart at 3 months. The secondary endpoints include change in LVEF from baseline measured by a CT scan of the heart at 12 months, in-hospital procedural related morbidity / mortality and assessment of major adverse cardiac events (MACE; death, heart attack, need for repeat heart revascularisation), change in exercise capacity and NYHA class at 3 months and 12 months respectively. The NYHA classification is a quantitative way of assessing a patient's heart failure symptoms. It places patients into one of four categories (I - IV).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2021


Arm Intervention/treatment
BMMNC intervention arm
Bone marrow derived mononuclear cells and G-CSF
Biological: Bone marrow derived mononuclear cells and G-CSF
Intra-coronary infusion




Primary Outcome Measures :
  1. Change in Left Ventricular Ejection Fraction Imaging [ Time Frame: Baseline to 3 Months ]
    Change in Left Ventricular Ejection Fraction on Cardiac CT


Secondary Outcome Measures :
  1. Change in Left Ventricular Ejection Fraction [ Time Frame: Baseline to 12 months ]
    Change in Left Ventricular Ejection Fraction on Cardiac CT

  2. Blood parameters [ Time Frame: Baseline to 1,3 and 12 months ]
    Change in NT-proBNP, troponin, creatine kinase, renal function and CRP

  3. Clinical outcomes [ Time Frame: 3 & 12 months ]
    MACE endpoints

  4. Change in exercise capacity 6 minutes walk test [ Time Frame: Baseline to 3 & 12 months ]
    Change distance covered measured in meters during a 6 minutes walking test.

  5. Change in NHYA classfication [ Time Frame: Baseline to 3 and 12 months. ]
    Change in heart failure symptoms as measured on NHYA classification as assessed by physician.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist.
  • NYHA class III or IV symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.
  • No other treatment options available as part of current best standard care.
  • LVEF ≤30% on the cardiac CT scan performed as part of the screening phase.

Exclusion Criteria:

  • NYHA I-II.
  • Documented latest ejection fraction >30% (any imaging modality)
  • Congenital heart disease.
  • Clinically significant valvular heart disease.
  • Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion & presence of LV thrombus)
  • Weight of patient that exceeds the maximum limit of the cardiac catheter laboratory table / CT scanner.
  • Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia.
  • Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
  • Previous cardiac surgery.
  • Contra-indication for bone marrow aspiration.
  • Known active infection at time of randomisation.
  • Positive virology tests.
  • Chronic inflammatory disease requiring on-going medication.
  • Concomitant disease with a life expectancy of less than one year
  • Follow-up impossible (no fixed abode, etc.)
  • Neoplastic disease without documented remission within the past 5 years.Patients on renal replacement therapy.
  • Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572660


Contacts
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Contact: Anthony Mathur 0203 765 8715 anthony.mathur@bartshealth.nhs.uk
Contact: Jessry Veerapen 0203 765 8708 dj.veerapen@bartshealth.nhs.uk

Locations
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United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Jessry Veerapen    0203 765 8708    dj.veerapen@bartshealth.nhs.uk   
Contact: Mohsin Hussain    0203 765 8704    mohsin.hussain2@bartshealth.nhs.uk   
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
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Principal Investigator: Anthony Mathur Barts & The London NHS Trust

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03572660     History of Changes
Other Study ID Numbers: Reda 012357
2018-001063-23 ( EudraCT Number )
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barts & The London NHS Trust:
stem cell
circulatory support
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs