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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02907749

Acronym

FP-PH

Enrollment

Registered

2016-09-20

Start date

2018-01-01

Completion date

2020-07-31

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension

Brief 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.

Interventions

DRUGSpironolactone and carvedilol

Patients are treated with carvedilol in combination with spironolactone.

DRUGCarvedilol

Patients are treated with carvedilol only.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Virtual portal pressure gradient(vPPG)	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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026