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

Heart Failure Clinical Trial

Official title:

Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03702062
• Other study ID #: HF1
• Status: Withdrawn
• Phase: N/A
• Start date: November 21, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure hospitalization	hospital inpatient admission or emergency room visit	12 months
Secondary	Heart failure mortality	Death from heart failure	12 months