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The Determination of Important Mechanical Patterns of Left Ventricular Efficiency-MV02 Study (DIMPLE)

This study is currently recruiting participants.
Verified June 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT01807819
First Posted: March 8, 2013
Last Update Posted: June 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
The purpose of this study is to determine if analysis of heart ultrasound images with new software programs will provide better understanding as to the specific heart problems that lead to symptoms of heart failure.

Condition Intervention
Heart Failure Other: Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Determination of Important Mechanical Patterns of Left Ventricular Efficiency-MV02 Study

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Correlation of myocardial strain with maximal oxygen consumption [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • Cardiovascular Hospitalization [ Time Frame: Baseline to 2 years ]
  • Cardiovascular Death [ Time Frame: Baseline to 2 years ]

Estimated Enrollment: 100
Actual Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heart Failure
Patients will undergo echocardiogram and exercise testing. Two year phone follow-up.
Other: Heart Failure
Patients will undergo echocardiogram and exercise testing. Two year phone follow-up.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients 18 years of age or older who are referred to our adult cardiovascular heart failure clinics for evaluation of heart failure or LV dysfunction
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older who are referred to our adult cardiovascular heart failure clinics for evaluation of heart failure or LV dysfunction.

Exclusion Criteria:

  • Patients with contraindications to exercise testing:(myocardial infarction within 2 days, unstable angina, uncontrolled cardiac arrhythmias, severe aortic stenosis, uncontrolled symptomatic heart failure, recent pulmonary embolism, recent myocarditis, history of aortic dissection, untreated ischemic CAD, blood pressure > 200/110, history of untreated tachy- or brady arrhythmia, hypertrophic cardiomyopathy, or inability to perform exercise because of physical or mental impairment) will be excluded from the study.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01807819


Contacts
Contact: John W Petersen, MD 352-273-9076

Locations
United States, Florida
University of Florida, Shands Cardiovascular Clinic Recruiting
Gainesville, Florida, United States, 32610
Contact: John W Petersen, MD    352-273-9076      
Principal Investigator: John W Petersen, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: John W Petersen, MD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01807819     History of Changes
Other Study ID Numbers: IRB201602538
27-2013 ( Other Identifier: uf legacy )
First Submitted: March 7, 2013
First Posted: March 8, 2013
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by University of Florida:
Heart Failure
Myocardial Strain
Functional Capacity

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases