Study on Mechanical and Electrical Alternans

• Conditions: Ischemia; Ventricular Arrhythmia; Heart Failure

• Registration Number: NCT01281241
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-10
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Study First Posted: 2011-01-21
• Last Update Posted: 2011-01-21
• Primary Completion: 2011-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of mechanical alternans and MTWA	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands