| ID | Type | Description | Link |
|---|---|---|---|
| R01DK046580 | U.S. NIH Grant/Contract | View source | |
| YALESM 6618 | Other Identifier | Yale School of Medicine |
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| Name | Class |
|---|---|
| Yale University | OTHER |
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The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol Maleate | Experimental | Dose titrated from 5 mg per day to up to 80 mg per day depending on heart rate |
|
| Placebo | Placebo Comparator | Timelol placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Varices | Development of varices | 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto J Groszmann, M.D. | Yale University School of Med. | Principal Investigator |
| Norman Grace, M.D. | Tufts University | |
| Jaime Bosch, M.D. | University of Barcelona | |
| Andrew Burroughs, M.D. | University of London | |
| Guadalupe Garcia-Tsao, M.D. | Yale University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University Sch. of Medicine | New Haven | Connecticut | 06520 | United States | ||
| VA CT Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1900306 | Background | Sarin SK, Groszmann RJ, Mosca PG, Rojkind M, Stadecker MJ, Bhatnagar R, Reuben A, Dayal Y. Propranolol ameliorates the development of portal-systemic shunting in a chronic murine schistosomiasis model of portal hypertension. J Clin Invest. 1991 Mar;87(3):1032-6. doi: 10.1172/JCI115062. | |
| 9178694 | Background | Escorsell A, Ferayorni L, Bosch J, Garcia-Pagan JC, Garcia-Tsao G, Grace ND, Rodes J, Groszmann RJ. The portal pressure response to beta-blockade is greater in cirrhotic patients without varices than in those with varices. Gastroenterology. 1997 Jun;112(6):2012-6. doi: 10.1053/gast.1997.v112.pm9178694. |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| West Haven |
| Connecticut |
| 06516 |
| United States |
| The Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
| Hospital Clinic I Provincial de Barcelona | Barcelona | Catalonia | Spain |
| Royal Free Hospital | Hampstead | London | NW32QG | United Kingdom |
| 16306522 | Result | Groszmann RJ, Garcia-Tsao G, Bosch J, Grace ND, Burroughs AK, Planas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Gao H, Makuch R; Portal Hypertension Collaborative Group. Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. N Engl J Med. 2005 Nov 24;353(21):2254-61. doi: 10.1056/NEJMoa044456. |
| 19303163 | Derived | Ripoll C, Groszmann RJ, Garcia-Tsao G, Bosch J, Grace N, Burroughs A, Planas R, Escorsell A, Garcia-Pagan JC, Makuch R, Patch D, Matloff DS; Portal Hypertension Collaborative Group. Hepatic venous pressure gradient predicts development of hepatocellular carcinoma independently of severity of cirrhosis. J Hepatol. 2009 May;50(5):923-8. doi: 10.1016/j.jhep.2009.01.014. Epub 2009 Mar 5. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |