Effects of Spironolactone on Fibrosis Progression and Portal Hypertension in Patients With Compensated Cirrhosis

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

Sponsors

Lead sponsor: Changqing Yang

Collaborator: Nanfang Hospital of Southern Medical University
Fudan University

Source Shanghai Tongji Hospital, Tongji University School of Medicine
Brief Summary

The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal hypertension in patients with compensated cirrhosis. The patients were nonrandomized according to the medical conditions determined by the physicians, in 3 arms (spironolactone start from 40mg once daily and increase every week with a maximum dose as 100mg once daily, carvedilol start from 6.25mg once daily and increase to 12.5mg once daily in next week if being tolerated, spironolactone in combination with carvedilol: spironolactone is added when carvedilol has reached the most tolerated dose). Portal pressure gradient by virtual hepatic venous pressure gradients based on enhanced CT, and liver elasticity by Fibroscan Medical Device are documented at baseline level and every six months after the treatment. Changes in serum fibrosis markers and liver function are monitored before and every 3 months after the treatment.

Overall Status Active, not recruiting
Start Date January 1, 2018
Completion Date June 1, 2020
Primary Completion Date June 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
liver elasticity as assessed by Fibroscan 6 months
Secondary Outcome
Measure Time Frame
Portal pressure gradient(PPG) as determined by a virtual PPG (vPPG) based on CT angiography and Doppler ultrasound 6 months
incidence rate of cirrhosis-related complications as recorded in patient history 3 months
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: Spironolactone Pill

Description: spironolactone starts from 40mg once daily and increase every week with a maximum dose as 100mg once daily

Arm group label: Spironolactone

Intervention type: Drug

Intervention name: Carvedilol

Description: carvedilol starts from 6.25mg once daily and increase to 12.5mg once daily in next week if being tolerated

Arm group label: Carvedilol

Intervention type: Drug

Intervention name: Spironolactone and Carvedilol

Description: spironolactone is added when carvedilol has reached the most tolerated dose

Arm group label: Spironolactone and Carvedilol

Eligibility

Criteria:

Inclusion Criteria:

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

- Proven portal hypertension by calculated virtual HVPG >12mmHg based on enhanced CT

- Child-Pugh score < 9

- Suspension of alcohol intake for at least 6 weeks before enrollment

Exclusion Criteria:

- Treatment with angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors in the last 2 months

- Renal insufficiency

- Hepatic encephalopathy at stage 2

- Contraindications to beta-blockers or spironolactone.

- Other organ fibrosis situations

- Malignant diseases

- Portal vein thrombosis

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jing Li, M.D. Study Director Shanghai Tongji Hospital, Tongji University School of Medicine
Location
facility Shanghai Tongji Hospital, Tongji University
Location Countries

China

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine

Investigator full name: Changqing Yang

Investigator title: Professor in Hepatology

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Spironolactone

Arm group type: Experimental

Arm group label: Carvedilol

Arm group type: Active Comparator

Arm group label: Spironolactone and Carvedilol

Arm group type: Active Comparator

Acronym FP-PH
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov