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CardiomyopathyNCT02010515

An Arrhythmia Risk Predictor Trial

An observational study of Cardiomyopathy and Heart Failure, run by University Medical Center Goettingen at 1 site in Germany.

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 prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment. Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiomyopathy, Heart Failure
How many people
282 participants
Where
1 siteGermany
Study dates
Jan 2008to May 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with ischemic or dilated cardiomyopathy and "standard indications" for ICD treatment. "Stamdard indications" are approved and strictly follow current guidelines, the decision on ICD implantation is based on left-ventricular ejection fraction or the history of malignant arrhythmia. i.e. secondary prevention of sudden cardiac death). Implantation procedure is performed at University Medical Center Goettingen.

Who may be able to join

  • ischemic or dilated cardiomyopathy
  • sinusrhythm
  • ICD indication strictly following current guidelines (primary and secondary prevention of SCD)
  • Age 18 years or older

Who cannot join

  • no consent
  • atrial fibrillation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Goettingen

    Göttingen, 37075

Other trials in Germany

About this study

Official title: Clinical-Electrophysiological Risk Marker Trial Goettingen

This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment.

Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.

Read more

Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies.

Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines.

Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.

Keywords
sudden cardiac death, risk stratification, t-wave alternans, Holter electrocardiography, heart rate turbulence
Medical subject headings
Cardiomyopathies, Heart Failure, Death, Sudden, Cardiac

What participants receive

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

Study groups in NCT02010515
Study groupRoleWhat they receive
Sinus rhythm, first ICD implantationNot described

What is being measured

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

  1. All-Cause Mortality

    Measured: 2008-2013

  2. First Appropriate ICD Shock

    First ICD discharge for malignant ventricular arrhythmia

    Measured: 2008-2013

Timeline

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

  1. First posted12 Dec 2013 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2013
  4. Study completionMay 2013

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 only
Time perspective
Prospective
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02010515
Sponsor's protocol ID
UMG-181211
Status last verified
Dec 2013
First submitted
9 Dec 2013
Last updated
12 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. doi: 10.1161/CIRCULATIONAHA.106.178233. Epub 2006 Aug 25. No abstract available.

    PubMed 16935995

  • Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol. 2008 Sep 30;52(14):1111-21. doi: 10.1016/j.jacc.2008.05.058.

    PubMed 18804736

  • Buxton AE, Lee KL, Hafley GE, Pires LA, Fisher JD, Gold MR, Josephson ME, Lehmann MH, Prystowsky EN; MUSTT Investigators. Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease: lessons from the MUSTT study. J Am Coll Cardiol. 2007 Sep 18;50(12):1150-7. doi: 10.1016/j.jacc.2007.04.095. Epub 2007 Sep 4.

    PubMed 17868806

  • Hohnloser SH, Ikeda T, Bloomfield DM, Dabbous OH, Cohen RJ; New Collective Author. T-wave alternans negative coronary patients with low ejection and benefit from defibrillator implantation. Lancet. 2003 Jul 12;362(9378):125-6. doi: 10.1016/s0140-6736(03)13865-2.

    PubMed 12867114

  • Buckingham TA, Thessen CC, Stevens LL, Redd RM, Kennedy HL. Effect of conduction defects on the signal-averaged electrocardiographic determination of late potentials. Am J Cardiol. 1988 Jun 1;61(15):1265-71. doi: 10.1016/0002-9149(88)91167-8.

    PubMed 3376884

  • Bigger JT Jr, Fleiss JL, Kleiger R, Miller JP, Rolnitzky LM. The relationships among ventricular arrhythmias, left ventricular dysfunction, and mortality in the 2 years after myocardial infarction. Circulation. 1984 Feb;69(2):250-8. doi: 10.1161/01.cir.69.2.250.

    PubMed 6690098

  • Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.

    PubMed 10227219

  • Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.

    PubMed 16714188

  • Seegers J, Bergau L, Exposito PM, Bauer A, Fischer TH, Luthje L, Hasenfuss G, Friede T, Zabel M. Prediction of Appropriate Shocks Using 24-Hour Holter Variables and T-Wave Alternans After First Implantable Cardioverter-Defibrillator Implantation in Patients With Ischemic or Nonischemic Cardiomyopathy. Am J Cardiol. 2016 Jul 1;118(1):86-94. doi: 10.1016/j.amjcard.2016.04.016. Epub 2016 Apr 22.

    PubMed 27189815

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathy and Heart Failure, run by University Medical Center Goettingen at 1 site in Germany.

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 2 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 12 Dec 2013. 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 Germany. 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?

All-Cause Mortality (time frame: 2008-2013). The study lists 2 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 NCT02010515, which also lists 9 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 12 Dec 2013.

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