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Study on Mechanical and Electrical Alternans

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01281241
Enrollment
10
Registered
2011-01-21
Start date
2010-09-30
Completion date
2012-06-30
Last updated
2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ischemia, Ventricular Arrhythmia

Keywords

MTWA, mechanical alternans

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence or absence of mechanical alternans and MTWA1 year

Secondary

MeasureTime frame
Differences in reduced or more preserved LVEF and the occurrence of the two phenomena1 year
The occurrence of ventricular tachyarrhythmic events.1 year
Influence of LV compliance on arrhythmogenesis of the infarction border zone.1 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026