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

NCT05928624 | Completed Results DMC FDA Device

• 1 other identifier: 22-36046
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis, Liver; Portal Hypertension; Ascites Hepatic

Outcome Measures

Primary Outcomes (1)

• Change in Mean Arterial Pressure

  The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.

  Baseline and 24 Weeks

Secondary Outcomes (1)

• Change in Ascites Burden

  Baseline and 24 Weeks

Study Arms (2)

Standard of Care

SHAM COMPARATOR

This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.

Other: Standard of Care

Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions

EXPERIMENTAL

This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.

Device: Withings Home Blood Pressure Device and Scale

Interventions

Withings Home Blood Pressure Device and Scale DEVICE

The intervention will be whether the data generated from home monitoring devices are shared with the clinical providers. The investigators are not testing the efficacy of these approved devices.

Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions

Standard of Care OTHER

Standard of Care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Interventions

Weights and Measures; Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Giuseppe Cullaro, MD MAS
• Organization: Columbia University

gc2576@cumc.columbia.edu

8454067438

Study Officials

• Giuseppe Cullaro, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: September 22, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)