This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a phase IV, randomized, double-blinded, placebo-controlled, crossover clinical trial. The main purpose of this trial is to examine the effects of angiotensin II (AT 1) receptor antagonist (valsartan) on the ventricular function and aortic elasticity of patients with diabetes mellitus and healthy controls. The study will be out-patient and last 14 months. Approximately 30 subjects (15 in each group) will be randomized to either placebo or valsartan or the first 6 months and to the opposite treatment the next 6 months. An 8-week washout period will separate the two treatment periods. Ventricular function and aortic elasticity will be measured using the MRI of the heart. The primary efficacy endpoints for the cardiac function (EF), stroke volume and cardiac output of the left and the right ventricles. The main vascular elasticity measurement will be the arterial compliance, stiffness index and pulse wave velocity. The primary population for the analysis for efficacy will be the population who completed the study. For safety, all subjects who enter the study will be evaluable.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001032-32
Application #
7606920
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2008-03-31
Budget Start
2007-04-01
Budget End
2008-03-31
Support Year
32
Fiscal Year
2007
Total Cost
$5,282
Indirect Cost
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Chung, Chen-Chih; Pimentel Maldonado, Daniela A; Jor'dan, Azizah J et al. (2018) Lower cerebral vasoreactivity as a predictor of gait speed decline in type 2 diabetes mellitus. J Neurol 265:2267-2276
Kline, Emily R; Seidman, Larry J; Cornblatt, Barbara A et al. (2018) Depression and clinical high-risk states: Baseline presentation of depressed vs. non-depressed participants in the NAPLS-2 cohort. Schizophr Res 192:357-363
Simpson, Norah S; Scott-Sutherland, Jennifer; Gautam, Shiva et al. (2018) Chronic exposure to insufficient sleep alters processes of pain habituation and sensitization. Pain 159:33-40
Dai, Weiying; Duan, Wenna; Alfaro, Freddy J et al. (2017) The resting perfusion pattern associates with functional decline in type 2 diabetes. Neurobiol Aging 60:192-202
Brosnahan, Godela M; Abebe, Kaleab Z; Rahbari-Oskoui, Frederic F et al. (2017) Effect of Statin Therapy on the Progression of Autosomal Dominant Polycystic Kidney Disease. A Secondary Analysis of the HALT PKD Trials. Curr Hypertens Rev 13:109-120
Torres, Vicente E; Abebe, Kaleab Z; Schrier, Robert W et al. (2017) Dietary salt restriction is beneficial to the management of autosomal dominant polycystic kidney disease. Kidney Int 91:493-500
Irazabal, María V; Abebe, Kaleab Z; Bae, Kyongtae Ty et al. (2017) Prognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial. Nephrol Dial Transplant 32:1857-1865
Seidman, Larry J; Shapiro, Daniel I; Stone, William S et al. (2016) Association of Neurocognition With Transition to Psychosis: Baseline Functioning in the Second Phase of the North American Prodrome Longitudinal Study. JAMA Psychiatry 73:1239-1248
Thermenos, Heidi W; Juelich, Richard J; DiChiara, Samantha R et al. (2016) Hyperactivity of caudate, parahippocampal, and prefrontal regions during working memory in never-medicated persons at clinical high-risk for psychosis. Schizophr Res 173:1-12

Showing the most recent 10 out of 642 publications