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Study on Mechanical and Electrical Alternans

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Active, not recruiting
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier:
First received: January 20, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
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.

Heart Failure
Ventricular Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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)

Resource links provided by NLM:

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Presence or absence of mechanical alternans and MTWA [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
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Please refer to this study by its identifier: NCT01281241

Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Arthur AM Wilde, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: A.A.M Wilde, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier: NCT01281241     History of Changes
Other Study ID Numbers: NL33244.018.10
Study First Received: January 20, 2011
Last Updated: January 20, 2011

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
mechanical alternans

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017