Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy

Completed

Conditions studied: Heart Failure

In brief

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)

Key facts

Study ID

NCT00158015

Run by

Hennepin Healthcare Research Institute

People needed

70

Starts

2004-10-01

Expected to finish

2007-09-01

Last updated by the study team

2012-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Metropolitan Cardiology consultants — Coon Rapids, Minnesota, United States
• Minnesota Heart Clinic — Edina, Minnesota, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• St. Paul Heart Clinic — Saint Paul, Minnesota, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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