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

Primary Purpose

Cirrhosis, Portal Hypertension

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Spironolactone and carvedilol

Carvedilol

About this trial

This is an interventional prevention trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shanghai Tongji Hospital, Tongji University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carvedilol

Spironolactone and carvedilol

Arm Description

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

Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose Spironolactone is added after carvedilol being tolerated, which starts with 20mg/d and increases to 40mg/d as a maintainence dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Liver stiffness measurement (LSM)

Detected using FibroScan

Occurence of portal hypertension-related complications

variceal bleeding, ascites, hepatic encephalopathy

Full Information

NCT ID

NCT02907749

First Posted

September 13, 2016

Last Updated

August 21, 2020

Sponsor

Changqing Yang

1. Study Identification

Unique Protocol Identification Number

NCT02907749

Brief Title

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

Acronym

FP-PH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Changqing Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Portal Hypertension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carvedilol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Spironolactone and carvedilol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Spironolactone and carvedilol

Other Intervention Name(s)

Combination therapy

Intervention Description

Patients are treated with carvedilol in combination with spironolactone.

Intervention Type

Drug

Intervention Name(s)

Carvedilol

Other Intervention Name(s)

Single therapy

Intervention Description

Patients are treated with carvedilol only.

Primary Outcome Measure Information:

Title

Virtual portal pressure gradient(vPPG)

Description

Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Liver stiffness measurement (LSM)

Description

Detected using FibroScan

Time Frame

6 months

Title

Occurence of portal hypertension-related complications

Description

variceal bleeding, ascites, hepatic encephalopathy

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Li, M.D.

Organizational Affiliation

Shanghai Tongji Hospital, Tongji University School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Tongji Hospital, Tongji University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

20065

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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