Clinical trial NCT01281241: Study on Mechanical and Electrical Alternans
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ischemia
Ventricular Arrhythmia
Keywords: MTWA
mechanical alternans
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital with a left ventricular ejection fraction (LVEF) under 35%, due to coronary artery disease with an indication for electrophysiological investigation.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence or absence of mechanical alternans and MTWA
timeFrame: 1 year
Secondary outcomes:
measure: Differences in reduced or more preserved LVEF and the occurrence of the two phenomena
timeFrame: 1 year
measure: The occurrence of ventricular tachyarrhythmic events.
timeFrame: 1 year
measure: Influence of LV compliance on arrhythmogenesis of the infarction border zone.
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Arthur AM Wilde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: