A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

Not Applicable

Completed

• Conditions: Portal Hypertension; Ascites Hepatic; Cirrhosis, Liver

• Registration Number: NCT05928624
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

Detailed Description

This is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-03
• Study Start: 2023-09-22
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2025-07
• Results First Submitted: 2025-07-02
• Results First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Results First Posted: 2025-07-22
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure	Baseline and 24 Weeks	The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.

Secondary Outcome Measures

Name	Time	Method
Change in Ascites Burden	Baseline and 24 Weeks	The investigators will compare the change in ascites burden, defined as the total volume of ascites removed during the study period, before and after utilization of the data generated from the home monitoring.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States