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

NCT03090425 | Completed DMC

• 1 other identifier: 01 GI 0205 KKS 1108
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Non Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philipps University Marburg: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Competence Network Heart Failure: collaborator

Related Publications (7)

• 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.

  PMID: 27390998 BACKGROUND

• 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.

  PMID: 24050898 BACKGROUND

• 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.

  PMID: 22892539 BACKGROUND

• 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.

  PMID: 21750094 BACKGROUND

• 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.

  PMID: 20145677 BACKGROUND

• 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.

  PMID: 26094644 RESULT

• 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.

  PMID: 29531765 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 24, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share