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

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ClinicalTrials.gov Identifier: NCT02907749
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Fudan University
Information provided by (Responsible Party):
Changqing Yang, 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.

Condition or disease Intervention/treatment Phase
Cirrhosis Portal Hypertension Drug: Spironolactone Pill Drug: Carvedilol Drug: Spironolactone and Carvedilol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Spironolactone on Fibrosis Progression and Portal Hypertension in Patients With Compensated Cirrhosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020


Arm Intervention/treatment
Experimental: Spironolactone Drug: Spironolactone Pill
spironolactone starts from 40mg once daily and increase every week with a maximum dose as 100mg once daily

Active Comparator: Carvedilol Drug: Carvedilol
carvedilol starts from 6.25mg once daily and increase to 12.5mg once daily in next week if being tolerated

Active Comparator: Spironolactone and Carvedilol Drug: Spironolactone and Carvedilol
spironolactone is added when carvedilol has reached the most tolerated dose




Primary Outcome Measures :
  1. liver elasticity as assessed by Fibroscan [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Portal pressure gradient(PPG) as determined by a virtual PPG (vPPG) based on CT angiography and Doppler ultrasound [ Time Frame: 6 months ]
  2. incidence rate of cirrhosis-related complications as recorded in patient history [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907749


Contacts
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Contact: Changqing Yang, M.D., Ph.D 13817802801 ext 86-21-66111075 cqyang@tongji.edu.cn
Contact: Jing Li, M.D. 15002116206 ext 86-21-66111075 lijingshengping@163.com

Locations
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China, Shanghai
Shanghai Tongji Hospital, Tongji University Recruiting
Shanghai, Shanghai, China, 20065
Contact: Jing Li, M.D.    +86 15002116206    lijingshengping@163.com   
Sponsors and Collaborators
Changqing Yang
Nanfang Hospital of Southern Medical University
Fudan University
Investigators
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Study Director: Jing Li, M.D. Shanghai Tongji Hospital, Tongji University School of Medicine

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Responsible Party: Changqing Yang, Professor in Hepatology, Shanghai Tongji Hospital, Tongji University School of Medicine
ClinicalTrials.gov Identifier: NCT02907749     History of Changes
Other Study ID Numbers: Yang-20160905
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Carvedilol
Spironolactone
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing