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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158015
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 4, 2012
Guidant Corporation
Information provided by:
Minneapolis Medical Research Foundation

Brief Summary:
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)

Condition or disease
Heart Failure

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 70 participants
Time Perspective: Prospective
Official Title: Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy
Study Start Date : October 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stable Heart failure subjects receiving CRT

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158015

United States, Minnesota
Metropolitan Cardiology consultants
Coon Rapids, Minnesota, United States, 55433
Minnesota Heart Clinic
Edina,, Minnesota, United States, 55417
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Regions Hospital
St. Paul, Minnesota, United States, 55101
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Guidant Corporation
Principal Investigator: Alan J Bank, MD St. Paul Heart Clinic

Responsible Party: Steven R. Goldsmith, Minneapolis medical research foundation Identifier: NCT00158015     History of Changes
Other Study ID Numbers: 1886-4
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Minneapolis Medical Research Foundation:
tissue Doppler Imaging
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases