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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01281241
Other study ID # NL33244.018.10
Secondary ID
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


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
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