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Heart FailureNCT02672163

Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure

A study testing CABG surgery and AADC therapy in people with Heart Failure, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
CABG surgery and AADC therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteFinland
Study dates
Feb 2016to Dec 2019
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained
  • Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
  • New York Heart Association (NYHA) Class II-IV heart failure symptoms

Who cannot join

  • Heart failure due to left ventricular outflow tract obstruction
  • History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
  • Stroke or other disabling condition within 3 months before screening
  • Severe valve disease or scheduled valve surgery
  • Renal dysfunction (GFR <84 ml/min/1.73m)
  • Other disease limiting life expectancy
  • Contraindications for coronary angiogram or MRI
  • Participation in some other clinical trial

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Annu Nummi

    Helsinki, 00029

Other trials in Finland

About this study

Official title: Epicardial Delivery of Autologous Atrial Appendage Micrografts During Coronary Artery Bypass Surgery - Safety and Feasibility Study

This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery.

Read the detailed description

The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.

Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.

Conditions
Heart Failure
Being tested
CABG surgery, AADC therapy
Keywords
autologous micrografts, heart failure, coronary artery bypass surgery, cell therapy, atrial appendage, epicardial cell delivery
Medical subject headings
Heart Failure

What participants receive

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

  • CABG surgeryProcedure or surgery

    Elective CABG surgery

  • AADC therapyProcedure or surgery

    Atrial appendage derived cells are placed on the site of a infarct scar with matrix sheet

Study groups in NCT02672163
Study groupRoleWhat they receive
AACD-Therapy groupExperimental6 patients are recruited to the AADC-therapy group. Autologous atrial appendage derived cells (AADCs) are harvested from the appendage tissue removed during the venal cannulation of bypass. The cells and their extracellular matrix are placed with tissue clue to Cormatrix-sheet and further on top of the myocardium in the area of infarction scar. The procedure is done simultaneously with CABG surgery. The patients will be carefully monitored after the operations and cardiac MRI and echocardiogram will be performed previously to surgery as well as during the follow ups.
Receives: Procedure: CABG surgery; Procedure: AADC therapy
Control groupActive comparator20 patients are recruited to form the control group. They are patients scheduled for elective CABG surgery and they meet the same inclusion and exclusion criteria as the therapy group. There patients are followed as the hospital protocol with out any additional imagination or blood tests.
Receives: Procedure: CABG surgery

What is being measured

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

  1. Safety; need for vasoactive medication

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  2. Safety; cardiac index in l/min/m

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  3. Safety; hemoglobin in g/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  4. Safety; oxygen saturation in the pulmonary arterial blood (SvO2) in %

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  5. Safety; serum potassium level in mmol/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  6. Safety; blood glucose level in mmol/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Measured: 6 months

  7. Safety; Left ventricular ejection fraction (EF) in %

    For assessing cardiac function during and after the operation by echocardiogram

    Measured: 6 months

  8. Safety; pericardial effusion in mm

    For assessing cardiac function after the operation by echocardiogram

    Measured: 6 months

  9. Safety: telemetric monitoring of rhythm

    For assessing cardiac function after the operation

    Measured: 6 months

  10. Feasibility: Success in completing the delivery of the cell sheet to the myocardium

    Measured in 0= success, 1= no success

    Measured: 6 months

  11. Feasibility: Waiting time in minutes for the cell sheet

    Waiting time in minutes for the finished cell sheet to be placed on the myocardium after doing all the required anastomoses

    Measured: 6 months

  12. Feasibility: Waiting time in minutes for the heart

    Waiting time in minutes for the the heart after doing all the anastomoses and before the cell sheet is finished

    Measured: 6 months

  13. Feasibility: Closing the right atrial appendage

    Closing the right atrial appendage after removing the standardized tissue piece for preparing the cell sheet. According to the hospital protocol, appendage is closed with purse string suture. 0 = no additional suturing needed, 1 = additional suturing needed.

    Measured: 6 months

Secondary outcomes (9)

  1. Left ventricular wall thickness

    Measured by MRI

    Measured: 6 months

  2. Change in the amount of myocardial scar tissue

    Measured by MRI

    Measured: 6 months

  3. Change in left ventricular ejection fraction

    Measured by MRI

    Measured: 6 months

  4. Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels

    Measured: 6 months

  5. New York Heart Association class

    Measured: 6 months

  6. Days in hospital

    Measured: 1 month

  7. Changes in the quality of life.

    measured by questionnaire

    Measured: 6 months

  8. Change in movement and diastolic function of left ventricular wall

    Measured by MRI

    Measured: 6 months

  9. Local changes in systolic and diastolic function

    Measured by echocardiogram

    Measured: 3 months

Timeline

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

  1. First posted3 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672163
Sponsor's protocol ID
180/13/03/02/2013
Status last verified
Mar 2020
First submitted
28 Dec 2015
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lehtinen M, Patila T, Vento A, Kankuri E, Suojaranta-Ylinen R, Poyhia R, Harjula A; Helsinki BMMC Collaboration. Prospective, randomized, double-blinded trial of bone marrow cell transplantation combined with coronary surgery - perioperative safety study. Interact Cardiovasc Thorac Surg. 2014 Dec;19(6):990-6. doi: 10.1093/icvts/ivu265. Epub 2014 Aug 20.

    PubMed 25142068

  • Lehtinen M, Schildt J, Ahonen A, Nikkinen P, Lauerma K, Sinisalo J, Kankuri E, Vento A, Patila T, Harjula A; Helsinki BMMC Collaboration. Combining FDG-PET and 99mTc-SPECT to predict functional outcome after coronary artery bypass surgery. Eur Heart J Cardiovasc Imaging. 2015 Sep;16(9):1023-30. doi: 10.1093/ehjci/jev032. Epub 2015 Mar 9.

    PubMed 25762563

  • Lehtinen M, Patila T, Kankuri E, Lauerma K, Sinisalo J, Laine M, Kupari M, Vento A, Harjula A; Helsinki BMMC Collaboration. Intramyocardial bone marrow mononuclear cell transplantation in ischemic heart failure: Long-term follow-up. J Heart Lung Transplant. 2015 Jul;34(7):899-905. doi: 10.1016/j.healun.2015.01.989. Epub 2015 Feb 7.

    PubMed 25797522

  • Lampinen M, Vento A, Laurikka J, Nystedt J, Mervaala E, Harjula A, Kankuri E. Rational Autologous Cell Sources For Therapy of Heart Failure - Vehicles and Targets For Gene and RNA Therapies. Curr Gene Ther. 2016;16(1):21-33. doi: 10.2174/1566523216666160104141809.

    PubMed 26725880

  • Nummi A, Mulari S, Stewart JA, Kivisto S, Teittinen K, Nieminen T, Lampinen M, Patila T, Sintonen H, Juvonen T, Kupari M, Suojaranta R, Kankuri E, Harjula A, Vento A; AADC consortium. Epicardial Transplantation of Autologous Cardiac Micrografts During Coronary Artery Bypass Surgery. Front Cardiovasc Med. 2021 Sep 14;8:726889. doi: 10.3389/fcvm.2021.726889. eCollection 2021.

    PubMed 34595223

  • Nummi A, Nieminen T, Patila T, Lampinen M, Lehtinen ML, Kivisto S, Holmstrom M, Wilkman E, Teittinen K, Laine M, Sinisalo J, Kupari M, Kankuri E, Juvonen T, Vento A, Suojaranta R, Harjula A; AADC consortium. Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study. Pilot Feasibility Stud. 2017 Dec 20;3:74. doi: 10.1186/s40814-017-0217-9. eCollection 2017.

    PubMed 29276625

Questions about this trial

What is this clinical trial studying?

A study testing CABG surgery and AADC therapy in people with Heart Failure, run by Helsinki University Central Hospital at 1 site in Finland.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety; need for vasoactive medication (time frame: 6 months). The study lists 13 primary outcomes in all. 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 NCT02672163, which also lists 6 linked publications.

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 5 Mar 2020.

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