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Completed

NCT Number: NCT02907749

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

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.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, 20065, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone and carvedilol

Drug

Patients are treated with carvedilol in combination with spironolactone.

Other names: Combination therapy

Carvedilol

Drug

Patients are treated with carvedilol only.

Other names: Single therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Liver stiffness measurement (LSM)

    Time frame: 6 months

    Detected using FibroScan

  2. Occurence of portal hypertension-related complications

    Time frame: 6 months

    variceal bleeding, ascites, hepatic encephalopathy

Sponsors and collaborators

Lead sponsor

Changqing Yang

Other

Registry information

Official study title

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

Acronym: FP-PH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2016
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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