Trial Outcomes & Findings for PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study) (NCT NCT01675544)

NCT ID: NCT01675544

Last Updated: 2015-11-30

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 46 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-11-30

Participant Flow

Participant milestones

Measure	Heart Failure Admission Patients admitted for acute decompensated heart failure Electrocardiogram: EKG voltage changes between admission and discharge Six minute walk test
Overall Study STARTED	46
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Heart Failure Admission Patients admitted for acute decompensated heart failure Electrocardiogram: EKG voltage changes between admission and discharge Six minute walk test
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Heart Failure Admission n=46 Participants Patients admitted for acute decompensated heart failure Electrocardiogram: EKG voltage changes between admission and discharge Six minute walk test
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Heart Failure Admission n=44 Participants Patients admitted for acute decompensated heart failure Electrocardiogram: EKG voltage changes between admission and discharge Six minute walk test
Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)	20 participants

PRIMARY outcome

Timeframe: 1 year

All cause mortality at 1 year

Outcome measures

Measure	Heart Failure Admission n=44 Participants Patients admitted for acute decompensated heart failure Electrocardiogram: EKG voltage changes between admission and discharge Six minute walk test
Mortality	9 participants

Adverse Events

Heart Failure Admission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Venkata M. Alla

Creighton University School of Medicine

Phone: (402) 280-4292

Email: venkataalla@creighton.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place