CirrhosisPhase 4FP-PHNCT02907749
Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis
A Phase 4 study testing Spironolactone and carvedilol and Carvedilol in people with Cirrhosis and Portal Hypertension, run by Changqing Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- Spironolactone and carvedilol and Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
Who cannot join
- 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
Show all 9Show fewer
- Portal vein thrombosis
- History of partial splenic embolization or splenectomy
- Moderate or tense ascites
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, 20065
About this study
Official title: Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease
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.
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- Spironolactone and carvedilol, Carvedilol
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone and carvedilolDrug
Also called Combination therapy
Patients are treated with carvedilol in combination with spironolactone.
CarvedilolDrug
Also called Single therapy
Patients are treated with carvedilol only.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Active comparator | Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose Receives: 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 Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Liver stiffness measurement (LSM)
Detected using FibroScan
Measured: 6 months
Occurence of portal hypertension-related complications
variceal bleeding, ascites, hepatic encephalopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changqing Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changqing Yang, Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Jing Li, M.D., Study director, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907749
- Sponsor's protocol ID
- Yang-20160905
- Acronym
- FP-PH
- Status last verified
- Aug 2020
- First submitted
- 13 Sep 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02907749
- Acronym / sponsor ID
- FP-PH / Yang-20160905
- Conditions
- Cirrhosis, Portal Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Changqing YangUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Active comparator | Drug: Spironolactone and carvedilolCarvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose |
| Spironolactone and carvedilol | Experimental | Drug: Carvedilol1. 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone and carvedilolAlso: Combination therapyPatients are treated with carvedilol in combination with spironolactone. | Drug | Carvedilol |
| CarvedilolAlso: Single therapyPatients are treated with carvedilol only. | Drug | Spironolactone and carvedilol |
Primary outcome
Virtual portal pressure gradient(vPPG)
Time frame: 6 months
Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound
2 secondary outcomes
Liver stiffness measurement (LSM)
Time frame: 6 months
Occurence of portal hypertension-related complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, M.D. study director
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone and carvedilol and Carvedilol in people with Cirrhosis and Portal Hypertension, run by Changqing Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual portal pressure gradient(vPPG) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.