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

NCT ID: NCT02907749

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Carvedilol

Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose

Group Type ACTIVE_COMPARATOR

Spironolactone and carvedilol

Intervention Type DRUG

Patients are treated with carvedilol in combination with spironolactone.

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

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

Patients are treated with carvedilol only.

Interventions

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Spironolactone and carvedilol

Patients are treated with carvedilol in combination with spironolactone.

Intervention Type DRUG

Carvedilol

Patients are treated with carvedilol only.

Intervention Type DRUG

Other Intervention Names

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Combination therapy Single therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changqing Yang

OTHER

Sponsor Role lead

Responsible Party

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Changqing Yang

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jing Li, M.D.

Role: STUDY_DIRECTOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

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Shanghai Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Yang-20160905

Identifier Type: -

Identifier Source: org_study_id

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