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

This study has been completed.
Sponsor:
Collaborator:
Guidant Corporation
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00158015
First received: September 8, 2005
Last updated: October 3, 2012
Last verified: October 2012
  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)


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Enrollment: 70
Study Start Date: October 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Stable Heart failure subjects receiving CRT

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158015

Locations
United States, Minnesota
Metropolitan Cardiology consultants
Coon Rapids, Minnesota, United States, 55433
Minnesota Heart Clinic
Edina,, Minnesota, United States, 55417
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
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
Investigators
Principal Investigator: Alan J Bank, MD St. Paul Heart Clinic
  More Information

No publications provided

Responsible Party: Steven R. Goldsmith, Minneapolis medical research foundation
ClinicalTrials.gov Identifier: NCT00158015     History of Changes
Other Study ID Numbers: 1886-4
Study First Received: September 8, 2005
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014