Heart FailurePREEMT-HFNCT01675544
PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)
An observational study of Heart Failure, run by Creighton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Electrocardiogram and Six minute walk test
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with acute decompensated heart failure
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this 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.
Read the 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
- 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
- Conditions
- Heart Failure
- Being tested
- Electrocardiogram, Six minute walk test
- Keywords
- Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramProcedure or surgery
Also called EKG
EKG voltage changes between admission and discharge
Six minute walk testProcedure or surgery
Also called 6-MWT
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Admission | Patients admitted for acute decompensated heart failure Receives: Procedure: Electrocardiogram; Procedure: Six minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
Measured: 1 year
Mortality
All cause mortality at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venkata M Alla, MBBS, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675544
- Sponsor's protocol ID
- 12-16350
- Acronym
- PREEMT-HF
- Status last verified
- Nov 2015
- First submitted
- 28 Aug 2012
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)
- ClinicalTrials.gov ID
- NCT01675544
- Acronym / sponsor ID
- PREEMT-HF / 12-16350
- Conditions
- Heart Failure
- Keywords
- Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Admission | – | Procedure: Electrocardiogram, Procedure: Six minute walk testPatients admitted for acute decompensated heart failure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with acute decompensated heart failure
Key inclusion criteria (4 listed)
- Patients > 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiogramAlso: EKGEKG voltage changes between admission and discharge | Procedure or surgery | Heart Failure Admission |
| Six minute walk testAlso: 6-MWT | Procedure or surgery | Heart Failure Admission |
Primary outcome
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
Time frame: 1 year
Mortality
Time frame: 1 year
All cause mortality at 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkata M Alla, MBBS principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.