This trial is active, not recruiting.

Conditions heart failure, ischemia, ventricular arrhythmia
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date September 2010
End date December 2011
Trial size 10 participants
Trial identifier NCT01281241, NL33244.018.10


The main objective is to investigate mechanical alternans and MTWA in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Presence or absence of mechanical alternans and MTWA
time frame: 1 year

Secondary Outcomes

Differences in reduced or more preserved LVEF and the occurrence of the two phenomena
time frame: 1 year
The occurrence of ventricular tachyarrhythmic events.
time frame: 1 year
Influence of LV compliance on arrhythmogenesis of the infarction border zone.
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Patients with heart failure caused by coronary artery disease - Indication for left ventricular radiofrequency (LV RF) ablation - LVEF ≤ 35% measured by echocardiogram or MRI Exclusion Criteria: - hemodynamically instable patients - age under 18 and over 85 years, - heart failure not caused by coronary artery disease - Severe co-morbidity

Additional Information

Official title The Connection Between Mechanical Alternans Measured by Pressure-Volume (PV) Loop Catheter in Patients With Ischemic Heart Failure and the Occurrence of Microvolt T Wave Alternans (MTWA)
Principal investigator Arthur AM Wilde, MD, PhD
Description In patients with severe heart failure and aortic valve disease mechanical alternans or pulsus alternans (a condition in which there is a beat-to-beat oscillation in the strength of cardiac muscle at a constant heart rate) is observed. The mechanisms linking mechanical to electrophysiological dysfunction in heart failure are still under investigation, but impaired calcium cycling is the most striking abnormality of failing myocytes, and is most responsible for contractile dysfunction. Yet it remains unclear how this influences susceptibility to arrhythmias. The MTWA is suggested as a risk marker to identify high risk patients for potential VTEs but the underlying mechanism is not completely understood. The aim of this study is to investigate this in a clinical setting by measuring LV parameters using a PV loop conductance catheter and generate TWA recording simultaneously to demonstrate a possible correlation between these two phenomena in patients with ischemic heart failure and find out if MTWA could turn into a more valuable risk factor. Our hypothesis is that alternating changes in LV filling explains the electrocardiogenesis of TWA by changing the position of the heart relative to the body surface electrodes in an alternating way.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).