NCT02907749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

September 13, 2016

Last Update Submit

August 21, 2020

Conditions

CirrhosisPortal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Virtual portal pressure gradient(vPPG)

    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 Outcomes (2)

  • Liver stiffness measurement (LSM)

    6 months

  • Occurence of portal hypertension-related complications

    6 months

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR

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

Drug: Spironolactone and carvedilol

Spironolactone and carvedilol

EXPERIMENTAL

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

Interventions

Spironolactone and carvedilolDRUG

Patients are treated with carvedilol in combination with spironolactone.

Also known as: Combination therapy
Carvedilol
CarvedilolDRUG

Patients are treated with carvedilol only.

Also known as: Single therapy
Spironolactone and carvedilol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, 20065, China

Location

MeSH Terms

Conditions

FibrosisHypertension, Portal

Interventions

SpironolactoneCarvedilolCombined Modality TherapyTherapeutics

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Jing Li, M.D.

    Shanghai Tongji Hospital, Tongji University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

July 31, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

CN(1)