NCT01807819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

5.5 years

First QC Date

March 7, 2013

Last Update Submit

June 17, 2024

Conditions

Heart Failure

Keywords

Heart FailureMyocardial StrainFunctional Capacity

Outcome Measures

Primary Outcomes (1)

  • Correlation of myocardial strain with maximal oxygen consumption

    Baseline

Secondary Outcomes (2)

  • Cardiovascular Hospitalization

    Baseline to 2 years

  • Cardiovascular Death

    Baseline to 2 years

Study Arms (1)

Heart Failure

Patients will undergo echocardiogram and exercise testing. Two year phone follow-up.

Other: Heart Failure

Interventions

Heart FailureOTHER

Patients will undergo echocardiogram and exercise testing. Two year phone follow-up.

Heart Failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida, Shands Cardiovascular Clinic

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John W Petersen, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

August 1, 2013

Primary Completion

January 31, 2019

Study Completion

June 7, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

US(1)