Study on Mechanical and Electrical Alternans
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Heart Failure Ischemia 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) |
- Presence or absence of mechanical alternans and MTWA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Differences in reduced or more preserved LVEF and the occurrence of the two phenomena [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- The occurrence of ventricular tachyarrhythmic events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Influence of LV compliance on arrhythmogenesis of the infarction border zone. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| 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) |
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Netherlands | |
| Academic Medical Center | |
| Amsterdam, Netherlands | |
| Principal Investigator: | Arthur AM Wilde, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
More Information
No publications provided
| Responsible Party: | A.A.M Wilde, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01281241 History of Changes |
| Other Study ID Numbers: | NL33244.018.10 |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
MTWA mechanical alternans |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Failure Ischemia |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013