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Cardiovascular Disease clinical trials at UCSF
16 in progress, 11 open to new patients

  • Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

    open to eligible people ages 15 years and up

    Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.

    San Francisco, California and other locations

  • Cardiovascular Inflammation Reduction Trial

    open to eligible people ages 18 years and up

    The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).

    Fresno, California and other locations

  • Designing Food Voucher Programs to Reduce Disparities in Healthy Diets

    open to eligible people ages 21 years and up

    Improving diets through increased food and vegetable (F&V) consumption significantly reduces the risk of cardiovascular disease (CVD). Programs increasing the accessibility and affordability of F&Vs among low-income Americans have been hindered by the food consumption cycle associated with poverty: the tendency to over-consume calories shortly after receiving funds at the beginning of each month, draining the budget for F&V purchases, or for all food purchases, by month's end. An emerging theory about dietary behavior suggests that providing funds for food in smaller installments distributed throughout the month will smooth the consumption cycle and improve healthy eating—counteracting the tendency to respond to lump sum, once-monthly funding installments by purchasing calorie-dense foods immediately after funds are received. The theory also suggests that funds targeted toward specific healthy foods (e.g., F&Vs) will improve diets more than untargeted funds, despite the inconvenience of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting by comparing alternative approaches for delivering food purchasing vouchers. We have established and tested the infrastructure to provide vouchers accepted by numerous food sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this infrastructure, we will conduct a randomized trial with a two-by-two factorial design, comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a sequential week of the month (lump sum versus distributed funding), and comparing vouchers restricted to F&V purchases to vouchers redeemable for any food (targeted versus untargeted funding). Low-income adults (N=288) recruited through our community partners will be randomized to one of four 6-month interventions: monthly targeted, monthly untargeted, weekly targeted, or weekly untargeted vouchers. Participants will be assessed through efficient verbal 24-hour dietary recalls validated among low-literacy populations, to determine daily consumption of F&Vs and metrics of overall dietary quality at months 0, 6 and 12 (6 months after vouchers end). Additional surveys will identify moderators and mediators of dietary improvement.

    San Francisco, California

  • Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease

    open to eligible people ages 20–65

    The purpose of this study is to find out how the amount of fat or sugar in a person's diet, or the number of meals eaten each day, affect the amount of fat that people's bodies make, the types of fats in the bloodstream, and how much fat is stored in the liver. The study is funded by the National Institutes of Health.

    San Francisco, California

  • Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

    open to eligible people ages 40 years and up

    The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20 individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.

    San Francisco, California and other locations

  • Endothelial Function and Vein Graft Remodeling

    open to eligible people ages 22–89

    The purpose of this study is to better understand why some vein bypass grafts develop narrowing. Evidence suggests that there is a relationship between inflammatory markers in the blood and the narrowing that occurs in blood vessels. In this study, we will look at inflammatory markers in the blood and how well the vein graft functions.

    San Francisco, California and other locations

  • Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

    open to eligible people ages 40–75

    The study is funded by the National Heart, Lung, and Blood Institute, with additional infrastructure support provided by the National Institute of Allergy and Infectious Diseases. People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART).

    San Francisco, California and other locations

  • International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

    open to eligible people ages 21 years and up

    The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction. B. Secondary Aims Major: To compare angina-related quality of life between groups. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups. Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III

    Fresno, California and other locations

  • Mechanical Support Measures of Adjustment and QOL

    open to eligible people ages 19 years and up

    The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

    San Francisco, California and other locations

  • One-Time DNA Study for Vasculitis

    open to eligible people ages 7 years and up

    The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

    San Francisco, California and other locations

  • The Mediterranean Full-Fat Dairy Study

    open to eligible people ages 21 years and up

    A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive oil as the main source of fat has been associated with reduced risk of cardiovascular disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory Committee. The strongest experimental support for this recommendation derives from the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease risk in comparison to either low-fat or Western dietary patterns. However, in none of these studies were comparisons made between the effects of Mediterranean-style diets with low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a Mediterranean dietary pattern based on that used in the PREDIMED study results in similar improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2) modification of the Mediterranean diet by replacing low-fat dairy products with high-fat dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase LDL-C and apoB but may raise large buoyant LDL particles compared with a standard Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in endothelial function compared to a Western diet.

    Berkeley, California

  • Dietary Protein Sources and Atherogenic Dyslipidemia

    Sorry, in progress, not accepting new patients

    There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake. The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.

    Berkeley, California

  • Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.

    San Francisco, California

  • Healthy Aging Longitudinal Study in Taiwan

    Sorry, in progress, not accepting new patients

    The general aim of this study is to establish a longitudinal cohort of older persons in order to examine the physiological, environmental and genetic risk factors for physical disability, frailty, cardiovascular disease, and neuropsychiatric disorders in older persons and to examine the benefit of healthy lifestyles. The findings from this study will provide information necessary for the development of effective health policy for aging people.

  • Mediators of Atherosclerosis in South Asians Living in America

    Sorry, accepting new patients by invitation only

    South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

    San Francisco, California and other locations

  • Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease

    Sorry, in progress, not accepting new patients

    Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of systemic inflammation that can persist even in patients with well-controlled joint disease. We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce cardiovascular risk) in these patients. The design of the trial is as follows: 18 month prospective, randomized, double-blind crossover trial comparing the addition of adalimumab to the addition of placebo. The primary endpoint is a change in endothelial cell function, as detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months of placebo.

    San Francisco, California