AzTrials
AzTrials

Non Ischemic CardiomyopathyIkariusNCT03090425

Inflammatory/Familial Dilated Cardiomyopathy: Is There a Link to Autoimmune Diseases? TP9a

An observational study of Non Ischemic Cardiomyopathy, run by Philipps University Marburg.

Completed

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

Official record
Search all trials

Trial summary

In a hitherto ill-defined proportion of patients with inflammatory/familial cardiomyopathy, the phenotype dilative cardiomyopathy (DCM) is assumed to be the endstage of a multifactorial etiopathogenetic pathophysiology. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non Ischemic Cardiomyopathy
How many people
320 participants
Where
No sites listed yet
Study dates
Jun 2016to 31 Dec 2018
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with non ischemic DCM: All patients underwent a careful history and clinical examination aswell as laboratory studies and echocardiographic assessment with 2-dimensional echocardiography. The diagnosis of DCM was made according to criteria of the position statement from the European Society of Cardiology working group on myocardial and pericardial diseases

Who may be able to join

  • Patients between 18 and 70 years of age were included if they had a left ventricular ejection fraction of 45% and a left ventricular end-diastolic diameter >56 mm estimated by echocardiography with no evidence of significant valve disease.

Who cannot join

  • Coronary artery disease (>50% diameter luminal stenosis in one or more epicardial vessels) was excluded in all patients by means of coronary angiography. Moreover, patients were excluded from the study if they demonstrated one or more of the following parameters: peripartum cardiomyopathy, history of myocardial infarction, severe systemic hypertension, alcohol abuse, and drug dependency.

About this study

Official title: Inflammatory/Familial Dilated Cardiomyopathy: Is There a Link to Autoimmune Diseases? TP9a of the KNHI Associated to the DZHK

In a hitherto ill-defined proportion of patients with inflammatory/familial cardiomyopathy, the phenotype dilative cardiomyopathy (DCM) is assumed to be the endstage of a multifactorial etiopathogenetic pathophysiology. Precipitating factors include enhanced autoimmunity, predisposition for viral infections, environmental factors in addition to a specific 'genetic background' of the individual patient. It is unresolved, whether the susceptibility to immunologically mediated myocardial damage reflects the presence of genetic risk factors shared by other autoimmune diseases, or is cardio-specific with individual predisposing factors. Aims of the project are the search for a genetic link or oredisposition to autoimmune diseases in patients with familial / inflammatory DCM.

Read the detailed description

Epidemiological investigations in patients with autoimmune diseases have shown that in addition to a specific genetic alteration secondary inducing factors are responsible for the onset of the disease, which may lead to different phenotypes of autoimmune diseases in a single family. The working hypothesis has been derived that inflammatory DCM is the endstage of an autoimmune cardiac disease that goes along with the activation of succeptibility genes, which are common to other autoimmune diseases.

Original aims of the project were:

  • inclusion of patients with dilated cardiomyopathy (ejection fraction <45%, left ventricular enddiastolic diameter > 56mm) and in addition
  • the inclusion of all relevant data regarding a possible familial, infectious or autoimmune etiology of the disease. A questionnaire was added to the CRFs, in order to ascertain data regarding a possible familial history for each patient not only for cardiac diseases, but also for autoimmune disorders. A pedigree of all patients was drawn. Data regarding a possible infectious or inflammatory etiology of the disease are available by investigation of the endomyocardial biopsy and peripheral blood. All data were included in the CRF. Derived from the data base, the biopsy and serum bank, further aims of the project are the search for a genetic link or genetic predisposition for autoimmune diseases in patients with DCM, especially inflammatory diseases.

To reach these aims, peripheral blood of all included patients was sent to the biomaterial bank in Berlin. DNA extracted from peripheral blood was investigated for the detection of genetic abnormalities in the genes for structural proteins, which are known to be associated with DCM. In addition, screening was done for several candidate genes in endomyocardial biopsies of patients with DCM using microchip technology and the investigation for polymorphisms in the HLA class II DQ locus in the patient cohort. Data if this Investigation were correlated with clinical outcome of the patients, who clinically were followed in total for 10 years. Right now the 10 year follow-up is ongoing.

What is being measured

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

  1. Genotype - phenotype correlation in patients with DCM of different etiology

    Correlation of different clinical and genetic marker with outcome (ejection fraction, left ventricular Diameter, composite of all-cause mortality or heart Transplantation

    Measured: 10-year clinical Follow-up will be performed from 12/2016 until June 2018

Timeline

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

  1. First posted24 Mar 2017
  2. Study startJun 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

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
Cohort
Time perspective
Prospective
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090425
Sponsor's protocol ID
01 GI 0205 KKS 1108
Acronym
Ikarius
Status last verified
Mar 2019
First submitted
14 Mar 2017
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Karatolios K, Holzendorf V, Richter A, Schieffer B, Pankuweit S; Competence Network Heart Failure Germany. Long-term outcome and predictors of outcome in patients with non-ischemic dilated cardiomyopathy. Int J Cardiol. 2016 Oct 1;220:608-12. doi: 10.1016/j.ijcard.2016.06.167. Epub 2016 Jun 26.

    PubMed 27390998

  • Pankuweit S, Ruppert V, Jonsdottir T, Muller HH, Meyer T; German Competence Network of Heart Failure. The HLA class II allele DQB1 0309 is associated with dilated cardiomyopathy. Gene. 2013 Dec 1;531(2):180-3. doi: 10.1016/j.gene.2013.09.022. Epub 2013 Sep 16.

    PubMed 24050898

  • Meyer T, Ruppert V, Ackermann S, Richter A, Perrot A, Sperling SR, Posch MG, Maisch B, Pankuweit S; German Competence Network Heart Failure. Novel mutations in the sarcomeric protein myopalladin in patients with dilated cardiomyopathy. Eur J Hum Genet. 2013 Mar;21(3):294-300. doi: 10.1038/ejhg.2012.173. Epub 2012 Aug 15.

    PubMed 22892539

  • Waldmuller S, Erdmann J, Binner P, Gelbrich G, Pankuweit S, Geier C, Timmermann B, Haremza J, Perrot A, Scheer S, Wachter R, Schulze-Waltrup N, Dermintzoglou A, Schonberger J, Zeh W, Jurmann B, Brodherr T, Borgel J, Farr M, Milting H, Blankenfeldt W, Reinhardt R, Ozcelik C, Osterziel KJ, Loeffler M, Maisch B, Regitz-Zagrosek V, Schunkert H, Scheffold T; German Competence Network Heart Failure. Novel correlations between the genotype and the phenotype of hypertrophic and dilated cardiomyopathy: results from the German Competence Network Heart Failure. Eur J Heart Fail. 2011 Nov;13(11):1185-92. doi: 10.1093/eurjhf/hfr074. Epub 2011 Jul 12.

    PubMed 21750094

  • Ruppert V, Meyer T, Struwe C, Petersen J, Perrot A, Posch MG, Ozcelik C, Richter A, Maisch B, Pankuweit S; German Heart Failure Network. Evidence for CTLA4 as a susceptibility gene for dilated cardiomyopathy. Eur J Hum Genet. 2010 Jun;18(6):694-9. doi: 10.1038/ejhg.2010.3. Epub 2010 Feb 10.

    PubMed 20145677

  • Pankuweit S, Luers C, Richter A, Ruppert V, Gelbrich G, Maisch B; German Competence Network Heart Failure. Influence of different aetiologies on clinical course and outcome in patients with dilated cardiomyopathy. Eur J Clin Invest. 2015 Sep;45(9):906-17. doi: 10.1111/eci.12483. Epub 2015 Aug 6.

    PubMed 26094644

  • Binas D, Daniel H, Richter A, Ruppert V, Schluter KD, Schieffer B, Pankuweit S. The prognostic value of sST2 and galectin-3 considering different aetiologies in non-ischaemic heart failure. Open Heart. 2018 Feb 26;5(1):e000750. doi: 10.1136/openhrt-2017-000750. eCollection 2018.

    PubMed 29531765

Questions about this trial

What is this clinical trial studying?

An observational study of Non Ischemic Cardiomyopathy, run by Philipps University Marburg.

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 1 inclusion and 1 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Genotype - phenotype correlation in patients with DCM of different etiology (time frame: 10-year clinical Follow-up will be performed from 12/2016 until June 2018). 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 NCT03090425, which also lists 7 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 25 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in