Study on Mechanical and Electrical Alternans

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01281241
• Other study ID #: NL33244.018.10
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2011
• Last updated: January 20, 2011
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2010
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Ischemia
• Ventricular Arrhythmia

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of mechanical alternans and MTWA		1 year	No
Secondary	Differences in reduced or more preserved LVEF and the occurrence of the two phenomena		1 year	No
Secondary	The occurrence of ventricular tachyarrhythmic events.		1 year	No
Secondary	Influence of LV compliance on arrhythmogenesis of the infarction border zone.		1 year	No