Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis (FP-PH)

August 21, 2020 updated by: Changqing Yang

Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease

The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20065
        • Shanghai Tongji Hospital, Tongji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings

Exclusion Criteria:

  • Treatment with β-blockers or diuretics in the last 3 months
  • Severe cardiopulmonary or renal insufficiency
  • Chronic alcohol abuse
  • Can't tolerate side effects of oral carvedilol or spironolactone
  • History of variceal bleeding
  • Malignancy
  • Portal vein thrombosis
  • History of partial splenic embolization or splenectomy
  • Moderate or tense ascites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carvedilol
Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose
Drug: Spironolactone and carvedilol
Patients are treated with carvedilol in combination with spironolactone.
Other Names:
  • Combination therapy
Experimental: Spironolactone and carvedilol
  1. Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose
  2. Spironolactone is added after carvedilol being tolerated, which starts with 20mg/d and increases to 40mg/d as a maintainence dose
Drug: Carvedilol
Patients are treated with carvedilol only.
Other Names:
  • Single therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virtual portal pressure gradient(vPPG)
Time Frame: 6 months
Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver stiffness measurement (LSM)
Time Frame: 6 months
Detected using FibroScan
6 months
Occurence of portal hypertension-related complications
Time Frame: 6 months
variceal bleeding, ascites, hepatic encephalopathy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changqing Yang

Investigators

  • Study Director: Jing Li, M.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yang-20160905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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