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

NCT02907749 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis
  • Portal Hypertension

Interventions

DRUG

Spironolactone and carvedilol

Patients are treated with carvedilol in combination with spironolactone.

DRUG

Carvedilol

Patients are treated with carvedilol only.

Sponsors & Collaborators

  • Changqing Yang

    lead OTHER

Principal Investigators

  • Jing Li, M.D. · Shanghai Tongji Hospital, Tongji University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-01-01
Completion
2020-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907749 on ClinicalTrials.gov