Purpose:
The purpose of this study is to assess whether tissue doppler imaging is useful in
predicting which patients will respond most to Cardiac Resynchronization therapy ( a type
of pacemaker)
Study summary:
Cardiac Resynchronization Therapy (CRT) is a newly developed therapy designed to improve
outcomes in patients with heart failure(HF). Recent studies have shown significant
symptomatic improvement and a decrease in hospitalization and mortality with CRT. However,
up to 30 % of patients do not experience improvement with this invasive and costly therapy.
Tissue Doppler Imaging (TDI) is emerging as an effective tool for non-invasively assessing
mechanical dyssynchrony of the left ventricle (LV) and may aid in the identification of LV
mechanical dyssynchrony to predict clinical response to CRT. PROMISE-CRT is designed to
address the following hypothesis: Changes in tissue doppler imaging measures of left
ventricular mechanical dyssynchrony from baseline to one week following cardiac
resynchronization therapy will correlate with the clinical response at three months.
Seventy HF patients clinically indicated to receive CRT will be enrolled in this six-month
multi-center study conducted in the Minneapolis-St. Paul metropolitan area. TDI analyses,
measures of clinical improvement and LV remodeling will be conducted one week, three months,
six months after CRT implementation.
Criteria:
Inclusion Criteria:
Moderate or severe heart failure defined as NYHA class III-IV despite optimal
pharmacological heart failure therapy.
Stable Heart failure as defined as not hospitalized within the last month. A 12 lead
electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a
sinus rate >50bpm, QRS duration >120ms and PR interval> 150ms Ejection Fraction <35%
documented within the last 6 months by one of the following methods: echo ( standard or
TEE) LV gram, or MUGA Clinically indicated to receive CRT Ability to complete all the
study visits including geographic stability
Exclusion criteria:
Serum creatinine >3.5 Have or had a Myocardial infarct, unstable angina, percutaneous
coronary intervention or coronary artery bypass graft during the preceding 30 days prior
to enrollment.
Have had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or
attempted LV lead placement.
Dyspnea believed by the physician to be primarily related to lung disease. Have an atrial
tachyarrhythmia that is permanent ( ie does not terminate spontaneously and cannot be
terminated with medical intervention)or persistent (can be terminated with medical
intervention but does not terminate spontaneously)within 90 days prior to enrollment Poor
sinus node function that MD predicts will require >70% atrial pacing. Inability to perform
the six minute walk. Life expectancy of less than 6 months due to other medical conditions
or expected to undergo heart transplant within the next 6 months.
Have a mechanical tricuspid heart valve. Hypertrophic obstructive cardiomyopathy. Patients
with a hypersensitivity to a 0.7mg nominal dose of dexamethasone. Surgically uncorrected
primary valvular heart disease. Patients who are currently enrolled in another
investigational study that would directly impact the treatment or outcome of the current
study.
Patients who are younger than 18 years of age, pregnant, or who are mentally incompetent
and cannot sign a patient informed consent.
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Location Contact:
Edina,, Minnesota 55417
United States
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