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7-day hemodynamic response to carvedilol combined with isosorbide mononitrate (ISMN) versus carvedilol alone in cirrhotic patients: a randomized controlled trial

7-day hemodynamic response to carvedilol combined with isosorbide mononitrate (ISMN) versus carvedilol alone in cirrhotic patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001091
Enrollment
Unknown
Registered
2010-11-08
Start date
2010-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

portal hypertension

Interventions

A:Carvedilol, orally taken for 7 days. The initial dosage is 12.5mg once daily, and the dosage is modulated for the target that the heart rate reduces below 55 per minute or the reduction > 20% of the
B:Carvedilol+Isosorbide Mononitrate Sustained Release Tablets, orally taken for 7days. The initial dosage of carvedilol is 12.5mg once daily, and ISMN 30mg daily. The dosage is modulated for the targe

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 75 years old; 2. Able and willing to provide signed informed consent; 3. Cirrhosis; 4. Presence of endoscopcally proven esophagogastric varices; 5. Baseline hepatic venous pressure gradient(HVPG) >=10mmHg.

Exclusion criteria

Exclusion criteria: 1. Non-cirrhotic portal hypertension; 2. Child-pugh score >13; 3. Contraindications to carvedilol or ISMN; 4. Presence of severe systemic illness (cardiorespiratory failure, acrive sepsis, renal failure); 5. Previous pharmacological treatment (beta or alpha adrenergic blockers, nitrates); 6. Uncontrolled hepatic encephalopathy; 7. Pregnant or lactating women; 8. Patients who do not give informed consent.

Design outcomes

Secondary

MeasureTime frame
diameter of portal vein;mean artery pressure;velocity of portal vein flow;blood flow of portal vein;heart rate;

Primary

MeasureTime frame
HVP;

Countries

China

Contacts

Public ContactChunqing Zhang
zhchqing@medmail.com.cn+86 15168886028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026