PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)
PREEMT-HF
1 other identifier
observational
46
1 country
1
Brief Summary
Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with acute heart failure can identify patients at risk for recurrent admissions for heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
September 29, 2014
CompletedNovember 30, 2015
November 1, 2015
1.8 years
August 28, 2012
September 25, 2014
November 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
1 year
Mortality
All cause mortality at 1 year
1 year
Study Arms (1)
Heart Failure Admission
Patients admitted for acute decompensated heart failure
Interventions
EKG voltage changes between admission and discharge
Eligibility Criteria
Patients admitted with acute decompensated heart failure
You may qualify if:
- Patients \> 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria:
- Evidence of systemic congestion (manifested by any 2 of the following criteria: jugular venous distension, edema, pulmonary rales, Left ventricular S3, or radiographic evidence of pulmonary venous congestion)
- Elevated Brain natriuretic peptide
- Need for at least 1 dose of intravenous loop diuretic
You may not qualify if:
- Cardiogenic shock, Acute coronary syndromes (patients with mild elevation in troponin related to heart failure will not be excluded), patients who are admitted for another principal problem and develop ADHF in the hospital, pregnant females, end stage renal disease on hemodialysis, expected survival \< 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Venkata M. Alla
- Organization
- Creighton University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Venkata M Alla, MBBS
Creighton University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 30, 2015
Results First Posted
September 29, 2014
Record last verified: 2015-11