Heart Failure
Conditions
Keywords
Heart failure
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.
Detailed description
Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted with acute decompensated heart failure (ADHF). Secondary Objectives 1. Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a composite of 1 year mortality and HFH in patients admitted with ADHF. 2. Determine the ability of proportionate pulse pressure, orthostatic blood pressure changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to predict HFH and mortality
Interventions
PROCEDUREElectrocardiogram
EKG voltage changes between admission and discharge
PROCEDURESix minute walk test
Sponsors
Creighton University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria: 1. 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) 2. Elevated Brain natriuretic peptide 3. Need for at least 1 dose of intravenous loop diuretic
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF) | 1 year | — |
| Mortality | 1 year | All cause mortality at 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heart Failure Admission Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Heart Failure Admission |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Failure Admission | Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF) | 20 participants |
Primary
Mortality
All cause mortality at 1 year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Failure Admission | Mortality | 9 participants |