Portal Hypertension GastropathyPhase 4PREDESCINCT01059396

Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal

A Phase 4 study testing propranolol and carvedilol in people with Portal Hypertension Gastropathy and Esophageal Varices, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis
What is being tested?: propranolol and carvedilol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: 8 sitesSpain
Study dates: 28 Jan 2010to 15 Jul 2015
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between 18 and 80 years old.
With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image.
No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (<3 months before randomization).
Absence of ascites demonstrated by a recent ultrasound (<3 months before the randomization).
informed consent

Who cannot join

previous decompensation of liver cirrhosis associated with portal hypertension.
GPVH <10 mmHg.
Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein.
Hepatocellular carcinoma demonstrated by two imaging tests.
Bilirubin> 3 mg / dl (or> 50 micromol / l), platelets <30 x10E9/lo Quick <30%.
Presence of renal insufficiency (serum creatinine> 2 mg / dl or> 200 micromol / l).

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Any comorbidity involving a therapeutic limitation and / or a prognosis of life <12 months.
Absolute contraindication to treatment with β-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma)
Hypersensitivity to β-blockers.
Pregnancy or lactation.
To receive anticoagulant treatment.
Past treatment with nitrated or β-blockers in the two weeks prior inclusion.
Cirrhosis C virus active antiviral therapy.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Spain8 sites

Hospital German Trias i Pujol
Badalona
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital de la Vall d'Hebron
Barcelona
Hospital Arnau de Vilanova
Lleida
Clínica Puerta del Hierro
Madrid
Hospital Gregorio Marañón
Madrid
Hospital Ramón y Cajal
Madrid

Other trials in Spain

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study on the Effectiveness of Treatment With Beta-blockers to Prevent Decompensation of Cirrhosis With Portal Hypertension

This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension.

Conditions: Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis, Hepatic Encephalopathy, Ascites
Being tested: propranolol, carvedilol, placebo
Medical subject headings: Esophageal and Gastric Varices, Hepatic Encephalopathy, Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propranololDrug
GPVH ≥ 10 mmHg - responders: propranolol.
carvedilolDrug
GPVH ≥ 10 mmHg nonresponders: carvedilol.
placeboDrug
placebo propranolol / carvedilol

Study groups in NCT01059396
Study group	Role	What they receive
Propranolol	Experimental	Not described Receives: Drug: propranolol
carvedilol	Experimental	Not described Receives: Drug: carvedilol
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Appearance of complications of portal hypertension: bleeding (caused by portal hypertension gastropathy and / or esophageal varices), ascites and / or spontaneous bacterial peritonitis(PBE), hepatic encephalopathy. Death from any cause.
Measured: 3 years

Secondary outcomes (4)

Compare the appearance of each of the complications of portal hypertension (ascites, SBP and other bacterial infections, varicose veins or signs of high risk, upper gastrointestinal bleeding portal hypertension, hepatic encephalopathy).
Measured: 3 years
Assess the development of liver failure.
Measured: 3 years
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
Measured: 3 years
To assess survival.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 201015 Jul 2015

First posted29 Jan 2010 (estimated)
Study start28 Jan 2010
Primary completion15 Jul 2015
Study completion15 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Portal Hypertension GastropathyStudies of the same condition, open and under way.
More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01059396
Sponsor's protocol ID: PREDESCI
Acronym: PREDESCI
Status last verified: Jan 2017
First submitted: 28 Jan 2010
Last updated: 22 Aug 2017
Results posted: No
Data monitoring committee: No

Publications

Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Brujats A, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J; PreDesCI Study Investigators. Bacterial infections adversely influence the risk of decompensation and survival in compensated cirrhosis. J Hepatol. 2021 Sep;75(3):589-599. doi: 10.1016/j.jhep.2021.04.022. Epub 2021 Apr 24.
PubMed 33905794
Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
PubMed 30910320

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study on the Effectiveness of Treatment With Beta-blockers to Prevent Decompensation of Cirrhosis With Portal Hypertension
ClinicalTrials.gov ID: NCT01059396
Acronym / sponsor ID: PREDESCI / PREDESCI
Conditions: Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis, Hepatic Encephalopathy, Ascites
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
Study start: 28 Jan 2010 (actual)
Primary completion: 15 Jul 2015 (actual)
Study completion: 15 Jul 2015 (actual)
First posted: 29 Jan 2010 (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.

This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Propranolol	Experimental	Drug: propranolol
carvedilol	Experimental	Drug: carvedilol
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Between 18 and 80 years old.
With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image.
No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (<3 months before randomization).
Absence of ascites demonstrated by a recent ultrasound (<3 months before the randomization).
informed consent

Key exclusion criteria (13 listed)

previous decompensation of liver cirrhosis associated with portal hypertension.
GPVH <10 mmHg.
Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein.
Hepatocellular carcinoma demonstrated by two imaging tests.
Bilirubin> 3 mg / dl (or> 50 micromol / l), platelets <30 x10E9/lo Quick <30%.

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
propranololGPVH ≥ 10 mmHg - responders: propranolol.	Drug	Propranolol
carvedilolGPVH ≥ 10 mmHg nonresponders: carvedilol.	Drug	carvedilol
placeboplacebo propranolol / carvedilol	Drug	Placebo

Primary outcome

Appearance of complications of portal hypertension: bleeding (caused by portal hypertension gastropathy and / or esophageal varices), ascites and / or spontaneous bacterial peritonitis(PBE), hepatic encephalopathy. Death from any cause.
Time frame: 3 years

4 secondary outcomes

Compare the appearance of each of the complications of portal hypertension (ascites, SBP and other bacterial infections, varicose veins or signs of high risk, upper gastrointestinal bleeding portal hypertension, hepatic encephalopathy).
Time frame: 3 years
Assess the development of liver failure.
Time frame: 3 years
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
Time frame: 3 years
To assess survival.
Time frame: 3 years

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 22 Aug 2017.
Derived from this study: PubMed 33905794Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Brujats A, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J; PreDesCI Study Investigators. Bacterial infections adversely influence the risk of decompensation and survival in compensated cirrhosis. J Hepatol. 2021 Sep;75(3):589-599. doi: 10.1016/j.jhep.2021.04.022. Epub 2021 Apr 24.
Derived from this study: PubMed 30910320Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.

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.

Càndid Villanueva Sánchez, MD principal investigator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 13 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. 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. Some participants in this study may receive a placebo. 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?

Appearance of complications of portal hypertension: bleeding (caused by portal hypertension gastropathy and / or esophageal varices), ascites and / or spontaneous bacterial peritonitis(PBE), hepatic encephalopathy. Death from any cause. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01059396, which also lists 2 linked publications.

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 22 Aug 2017.