51 Clinical Trials for Various Conditions
The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.
This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery. Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group). The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.
This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of anticipated study procedures.
The Supermarket and Web-based Intervention targeting Nutrition (SuperWIN) for cardiovascular risk reduction is a novel, randomized controlled trial aimed at increasing diet quality and decreasing cardiovascular risk. SuperWIN will deliver individualized, nutrition education at the point-of-purchase (POP), either in the aisles of the physical store or via online shopping platforms coupled with other modern software tools.
Background and Rationale Cardiovascular disease is highly prevalent in the kidney transplant population, accounting for approximately 40% of all deaths and significant morbidity. The morbidity and mortality experienced by kidney transplant recipient's results from an excess of pre-transplant risk factors that are exacerbated by kidney transplantation along with the development of novel risk factors. Hypertension (HTN) is the most consistent cardiovascuar disease risk factor in transplant recipients.. A large number of studies have been done in the general population comparing ambulatory blood pressure monitoring (ABPM) to casual, office based and home measures of blood pressure (BP). The results have clearly demonstrated that ABPM gives a more accurate representation of BP and arguably should be used as part of routine patient care. ABPM has been shown to reveal patients both with white-coat and with masked HTN, nocturnal HTN and lack of nocturnal dipping. Ambulatory BP measures afford us a non-invasive, highly accurate way to evaluate and treat kidney transplant recipients. Live kidney donors (LKD) have significantly expanded the supply of critical organs. Of paramount importance of course has always been donor safety. As a result, candidates are known to be healthy at the time of donation. Ambulatory blood pressure monitoring allows a unique opportunity to examine the effects of live kidney donation on the blood pressure profiles of LKD. Methods Study Design: Prospective, 5-year, single center study of ABPM, cardiovascular and graft outcomes in incident and prevalent live kidney donors, kidney and kidney-pancreas transplant candidates and recipients.
The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.
The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.
The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.
Researchers are trying to assess the appropriate dose of estrogen for decreasing the risk of cardiovascular disease in women who have removal of their ovaries at a young age, before the age of 46 years.
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians.
The Diabetes Prevention Program (DPP), a large research study conducted in the United States, found that lifestyle intervention was effective in lowering risk for development of type 2 diabetes. It is important to evaluate the DPP lifestyle interventions in "real world" settings. The purpose of this project is to test an adapted version of the DPP lifestyle intervention in several community settings, including a worksite, a health care facility (primary care practice and local community centers dedicated to older adults.
This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.
The purpose of this study is to evaluate the acute, postprandial effects and mechanism of action of various walnut components (separated nut skins, de-fatted nut meat, nut oil) versus whole walnuts on oxidative stress, inflammation and measures of platelet and endothelial function in healthy adults with moderately elevated cholesterol levels.
Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD.
The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with hypertensive disorders of pregnancy, to improve cardiovascular risk score postpartum. For this, 76 individuals with hypertensive disorders of pregnancy (HDP) will be randomized to atorvastatin 10mg or placebo, which will be started in the postpartum period after cessation of breast feeding and continued for 3 months.
Cardiovascular (CV) disease is the number one cause of death in American women, and all adult women are potentially at risk for CV disease. There are clear gender differences in the control of CV risk factors such as lipids, blood pressure, and intermediate diabetes outcomes nationally and within the VA, with women Veterans often at higher CV risk than their male counterparts. The combination of disparities and gender-specific CV risk factors suggest an urgent need for CV risk factor management in women Veterans. As one project in the Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI, the objectives of "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" are to implement and evaluate a CV risk reduction toolkit (CV toolkit) designed to increase identification of CV risk among Women Veterans, enhance patient/provider communication about their risk, and increase Women Veterans' engagement and retention in relevant health services including referrals to key health programs (e.g., MOVE!, dieticians, health coaches, and CV specialists as needed). The initial CV Toolkit includes four components: (1) Patient education/activation tools including educational materials and a patient CV self-screener to help make CV risk discussion a priority for women before they enter the exam room; (2) A CV risk assessment computerized template to systematically capture CV disease risk factor history and data from the medical record and then facilitate referrals to Gateway to Healthy Living program and other CV risk reduction services/programs; (3) Provider information and education programs as well as referral tools to internal services; and (4) The Gateway to Healthy Living, a facilitated goal-setting group tailored for women Veterans. The goal is to implement the CV Toolkit at four VA facilities with comprehensive women's health clinics. The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. For the nonrandomized stepped wedge design, each phase represents when one site moved from inactive to active implementation. It was pre-specified for the non-randomized design to evaluate the outcomes as the odds ratio of active intervention versus inactive for the overall study period and not by individual site/phase. This is a function of the use of the non-randomized design. Since the order of sites being introduced into the active intervention is not random, probabilistically the individual site results are not as meaningful here as they would be in a randomized stepped wedge design. Also, mixed methods implementation evaluations will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement will be prioritized. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, impact and facilitate spread.
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.
Rural populations in the U.S. are disproportionately burdened by cardiovascular disease and type 2 diabetes. Lifestyle modification interventions are needed that support long-term engagement in risk-reducing health behaviors. This trial will study the effects of a family-focused, lifestyle intervention that is culturally tailored for use with rural Hispanic and non-Hispanic adults. If successful, this community-based intervention has significant potential for broad dissemination to reduce cardiovascular disease and type 2 diabetes health disparities in rural U.S. communities.
A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.
The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.
Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
"Healing our Minds and Bodies" (HHMB) uses a a hybrid type II effectiveness/implementation study design to increase both patient and organizational readiness to address trauma and CVD risk among African American and Latino persons living with HIV or AIDS (PLWHIV).
The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.