Skip to main content
OpenTrials
Completed

NCT Number: NCT01675544

PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

About this study

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

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

Electrocardiogram

Procedure

EKG voltage changes between admission and discharge

Other names: EKG

Six minute walk test

Procedure

Other names: 6-MWT

Primary outcomes

  1. Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)

    Time frame: 1 year

  2. Mortality

    Time frame: 1 year

    All cause mortality at 1 year

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Acronym: PREEMT-HF

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2012
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.