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Evaluating risk factors for cirrhosis progression and response to statin therapy among a cohort of patients with cirrhosis

Award Number: U01DK130185
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Evaluating risk factors for cirrhosis progression and response to statin therapy among a cohort of patients with cirrhosis - E Despite advances in the treatment of hepatitis C virus (HCV), the number of liver disease-related deaths has increased annually since 2009 due to: 1) liver disease from non-alcoholic steatohepatitis (NASH) and alcohol-induced liver disease; and 2) mortality from hepatocellular carcinoma (HCC). The time course to progress from compensated to decompensated cirrhosis varies based on many factors, such as etiology of liver disease and medical co-morbidities. To better identify patients at greatest risk of hepatic decompensation requires a cohort of patients with varying etiologies of liver disease leading to compensated cirrhosis. Another population that has been shown to have increased risk of hepatic decompensation, and worse survival are HIV-infected patients. However, these data have been largely restricted to patients with HIV and viral hepatitis. In addition to identifying the trajectory of compensated cirrhosis, there is a need to identify therapeutics to slow progression. There are several lines of evidence to suggest that statins slow cirrhosis progression and/or decrease the risk of decompensation. However, there are limited prospective data to identify a benefit of statins among patients with compensated cirrhosis. This underscores the need to establish the safety and efficacy of statins to prevent hepatic decompensation in a US population, and to assess what may affect the response to statin therapy among patients with compensated cirrhosis. Our overarching goal is to develop a longitudinal prospective cohort study of patients with compensated cirrhosis to assess trajectories of hepatic stiffness and time to hepatic decompensation. We will enroll a subset with clinically significant portal hypertension in a randomized controlled trial of rosuvastatin. We seek to address these aims to: 1) identify factors associated with progression from compensated to decompensated cirrhosis; 2) develop risk models to stratify patients with compensated cirrhosis at risk for hepatic decompensation; and 3) determine whether rosuvastatin slows progression of liver stiffness among patients with compensated cirrhosis.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $388,501 )
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/26/2025	NON-COMPETING CONTINUATION	$388,501
														Subtotal = $388,501

Issue Date FY: 2024 ( Subtotal = $430,380 )
2024	2024	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/13/2024	NON-COMPETING CONTINUATION	$430,380
														Subtotal = $430,380

Issue Date FY: 2023 ( Subtotal = $480,289 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/17/2023	NON-COMPETING CONTINUATION	$480,289
														Subtotal = $480,289

Issue Date FY: 2022 ( Subtotal = $425,398 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	9/7/2022	NON-COMPETING CONTINUATION	$425,398
														Subtotal = $425,398

Issue Date FY: 2021 ( Subtotal = $311,198 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2021	NEW	$311,198
														Subtotal = $311,198

Grand Total All Awards = $2,035,766

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Evaluating risk factors for cirrhosis progression and response to statin therapy among a cohort of patients with cirrhosis

Award Number: U01DK130185

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/22/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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