NIH Grant Funds Clinical Research on Cirrhosis

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Weill Cornell Medicine has received a $2 million grant from the National Institutes of Health (NIH) to participate in a multicenter clinical initiative focused on understanding and treating cirrhosis, scarring of the liver that leads to the organ’s failure and increases the risk of liver cancer.

Under the five-year program, as part of the National Institute of Diabetes and Digestive and Kidney Diseases' new Liver Cirrhosis Network, the investigators will design a study that includes patients with cirrhosis caused by several different underlying conditions and follows them over a period of several years. They will also design and implement a clinical trial to determine if statins can prevent clinical progression, complications and cancer in patients with cirrhosis of all causes. The project is part of a broader grant, which also includes investigators from nine other leading institutions around the country.

“Cirrhosis is the 12th leading cause of death in the United States, and it’s increasing in its incidence," said lead principal investigator Dr. Robert S. Brown, Jr., chief of the Division of Gastroenterology and Hepatology and the Gladys and Roland Harriman Professor of Medicine at Weill Cornell Medicine and a professor of clinical medicine at Columbia University Vagelos College of Physicians and Surgeons. “Longitudinal studies of the long-term outcomes of cirrhosis, as well as research on interventions that could improve those outcomes, are clearly lacking. The NIH has recognized this, and the appointment of Weill Cornell Medicine as a leader of these new efforts shows how successful our liver program has become in recent years.”

One of the major causes of cirrhosis is non-alcohol related fatty liver disease (NAFLD), which is associated with obesity, metabolic syndrome and hyperlipidemia (high fat and cholesterol). NAFLD is currently the most rapidly growing type of liver disease in the United States. Chronic alcohol abuse and hepatitis infection are also leading causes of cirrhosis, which has few effective treatments. Once the liver has sustained this type of damage, it usually cannot be reversed. Liver transplants are the only definitive cure for the disease, but their use is limited by donor scarcity. They also incur high costs.

The study aims to follow thousands of patients from ten institutions for at least three years. “We plan to look at many aspects, including the state of patients’ liver disease, their comorbidities, and their diet, use of alcohol and medications,” said Dr. Brown, who is also director of the Center for Liver Disease and Transplantation at NewYork-Presbyterian. Other efforts will focus on the intestinal microbiome, behavioral elements and clinical decompensation, which is defined by acute deterioration of liver function.

For the clinical trial on statins, the investigators will test whether these cholesterol-lowering drugs can decrease the incidence of liver cancer and slow the progression of cirrhosis in people with liver disease. The rationale for this study is linked to the connection between NAFLD and cirrhosis. “There’s been a fear of using statins in people with liver disease because of their known complications related to the liver, but anecdotal evidence has suggested that statins are not only safe but may improve liver disease in certain patients,” Dr. Brown said. “This carefully controlled study will not only look at whether statins can improve outcomes — it will also look at the underlying mechanisms, and whether any improvements are due only to lipid-lowering or occur independent of that effect.”

The research will be conducted jointly with NewYork-Presbyterian/Columbia University Irving Medical Center and will also enroll patients from NewYork-Presbyterian Brooklyn Methodist Hospital and NewYork-Presbyterian Queens. “This will allow us to acquire a large cohort for our research that is not only diverse in terms of causes of cirrhosis, but also diverse across ethnic, racial, and socioeconomic backgrounds,” Dr. Brown said. Electronic health records will provide additional information about cirrhosis patients. Patients who enroll in the initiative will consent to their participation in human research and all collected clinical information will be deidentified to protect patient privacy.

Other participating institutions around the country will recruit patients and will contribute clinical and research expertise and data coordination. The grant is funded by several institutes within the NIH: the National Institute of Diabetes and Digestive and Kidney Diseases, the National Cancer Institute, and the National Institute on Alcohol Abuse and Alcoholism.

The other lead PI on the grant is Dr. Elizabeth C. Verna, the Frank Cardile Associate Professor of Medicine in the Division of Digestive and Liver Diseases at Columbia University Vagelos College of Physicians and Surgeons. The co-principal investigators are Dr. Russell Rosenblatt, assistant professor of medicine, and Dr. Brett Fortune, associate professor of medicine, both in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine, and Dr. Lorna Mills Dove, professor of medicine in the Department of Surgery at Columbia University Vagelos College of Physicians and Surgeons. Dr. Dove is also medical director of adult liver transplant in the Center for Liver Disease and Transplantation at NewYork-Presbyterian and Drs. Rosenblatt, Fortune, and Verna are all transplant hepatologists at the Center.

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