NCT01675544

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

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 29, 2014

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

August 28, 2012

Results QC Date

September 25, 2014

Last Update Submit

November 27, 2015

Conditions

Keywords

Heart failure

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

Procedure: ElectrocardiogramProcedure: Six minute walk test

Interventions

EKG voltage changes between admission and discharge

Also known as: EKG
Heart Failure Admission
Also known as: 6-MWT
Heart Failure Admission

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Venkata M. Alla
Organization
Creighton University School of Medicine

Study Officials

  • Venkata M Alla, MBBS

    Creighton University

    PRINCIPAL INVESTIGATOR

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

Locations