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Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting

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ClinicalTrials.gov Identifier: NCT03702062
Recruitment Status : Withdrawn (Study never started)
First Posted : October 10, 2018
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: 6 Minute Walk Test Smart phone Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting
Estimated Study Start Date : November 21, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Observational Arm
Participants will be asked to measure self-assessed 6 minute walk test via the smart phone application twice a week for 2 months after discharge from a heart failure hospitalization, and weekly thereafter for 6 months.
Diagnostic Test: 6 Minute Walk Test Smart phone Application
The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.




Primary Outcome Measures :
  1. Heart failure hospitalization [ Time Frame: 12 months ]
    hospital inpatient admission or emergency room visit


Secondary Outcome Measures :
  1. Heart failure mortality [ Time Frame: 12 months ]
    Death from heart failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized for decompensated heart failure
  • Age >=18 years
  • Owns a smart phone
  • Willing to measure self assess 6 minute walk test weekly

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702062


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Geoffrey Tison, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03702062    
Other Study ID Numbers: HF1
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases