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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02010515
Other study ID # UMG-181211
Secondary ID
Status Completed
Phase N/A
First received December 9, 2013
Last updated December 9, 2013
Start date January 2008
Est. completion date May 2013

Study information

Verified date December 2013
Source University Medical Center Goettingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ministry of Health
Study type Observational

Clinical 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 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ischemic or dilated cardiomyopathy

- sinusrhythm

- ICD indication strictly following current guidelines (primary and secondary prevention of SCD)

- Age 18 years or older

Exclusion Criteria:

- no consent

- atrial fibrillation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Medical Center Goettingen Goettingen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Bauer A, Kantelhardt JW, Barthel P, Schneider R, Mäkikallio T, Ulm K, Hnatkova K, Schömig 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Sep 4. — View Citation

Hohnloser SH, Ikeda T, Bloomfield DM, Dabbous OH, Cohen RJ. T-wave alternans negative coronary patients with low ejection and benefit from defibrillator implantation. Lancet. 2003 Jul 12;362(9378):125-6. — View Citation

Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schömig 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. — View Citation

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. Review. — View Citation

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. Epub 2006 Aug 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-Cause Mortality 2008-2013 No
Primary First Appropriate ICD Shock First ICD discharge for malignant ventricular arrhythmia 2008-2013 No
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