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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01807819
First received: March 7, 2013
Last updated: March 24, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Hospitalization [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]
  • Cardiovascular Death [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (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.
Other Name: Heart Failure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01807819     History of Changes
Other Study ID Numbers: 27-2013
Study First Received: March 7, 2013
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014