Hypertension Trial, Recruiting NCT06861075 Sponsor: University Hospital, Clermont-Ferrand Condition: Hypertension
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Hypertension Trial, Recruiting

NCT06861075
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have cirrhosis (scarring of the liver from any cause) with signs suggesting high blood pressure in the portal vein (the large vein supplying the liver), based on specific liver stiffness measurements and/or low platelet counts in the blood, as measured by established medical guidelines (confirm exact values with trial site)
  • People who have enlarged veins in the food pipe (oesophageal varices) that are considered at high risk of bleeding, based on their size or appearance
  • People who have imaging signs of high portal blood pressure, such as certain abnormal blood vessel connections or an enlarged spleen detected on scans
  • People who have a spleen stiffness measurement above a certain level on specialist scanning (confirm with trial site)
  • People who have never previously been treated with a specific type of heart-rate-lowering medication called cardioselective beta blockers
  • People who are enrolled in the French national health insurance system

Who may not be able to join:

  • People who have a known allergy or sensitivity to carvedilol (the study medication) or any of its ingredients
  • People who have severe heart failure with signs of fluid build-up in the body (such as swelling, fluid in the abdomen, or fluid in the lungs) or who need certain types of heart medications to keep their heart working
  • People who have certain types of abnormal heart rhythms (second or third-degree heart block), unless they already have a permanent pacemaker fitted
  • People whose resting heart rate is 50 beats per minute or lower
  • People who have a condition affecting the heart's natural pacemaker (sinus node disease)
  • People with very low blood pressure (systolic pressure below 85 mmHg)
  • People who have had a cardiogenic shock (when the heart suddenly cannot pump enough blood)
  • People with severe asthma, severe chronic lung disease, or a history of severe airway spasm
  • People who have had a severe allergic (anaphylactic) reaction in the past
  • People who have Raynaud's phenomenon (a condition affecting blood flow to the fingers and toes)
  • People who have severe narrowing of the arteries in the legs
  • People currently taking a medication called cimetidine (used for stomach acid)
  • People currently taking certain heart rhythm medications (class I antiarrhythmics), except for lidocaine
  • People who have high blood pressure in the arteries of the lungs (pulmonary arterial hypertension)
  • People who have a severe active episode of alcohol-related liver inflammation (based on a specific medical score, confirm with trial site)
  • People who currently have a significant level of confusion or reduced awareness caused by liver disease (hepatic encephalopathy grade 2 or above)
  • People who currently have a serious kidney complication linked to liver disease (hepato-renal syndrome)
  • People with a very large amount of fluid in the abdomen, if this makes a specialist stomach camera procedure (echo-endoscopy) not possible to perform
  • People who have previously had a bleeding episode from enlarged veins in the food pipe
  • People who have liver cancer, or whose liver cancer has been in remission for less than six months
  • People who have had a blood clot in the portal vein within the last six months, or still have one
  • People who have had certain types of stomach or digestive surgery that would prevent a specific measurement procedure from being carried out (confirm with trial site)
  • People taking certain blood-thinning or anti-clotting medications for a heart condition (except low-dose aspirin)
  • People with severe or end-stage kidney disease (kidney filtration rate below 30 mL/min)
  • People who are pregnant, breastfeeding, or planning to become pregnant during the trial period
  • People who are legally protected or under guardianship, or who have had their freedom restricted
  • People who are currently participating in another clinical research trial
  • People who do not understand the French language

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Armando Abergel, University Hospital, Clermont-Ferrand

Phone: +33473754963

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
16 April 2025
Est. completion
1 March 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Percentage of participants with a reduction of at least 10% in the porto-systemic gradient

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov