38 Clinical Trials for Various Conditions
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.
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 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.
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.
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.
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.
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 project proposes to provide the Complete Health Improvement Program (CHIP) initially up to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members) with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve self-management and the consequences of biometric factors that can be modified by lifestyle changes. The CHIP program is an educationally based, lifestyle intervention program that aims to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators expect that participants following the programs guidelines will lower their body mass index, cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent chronic disease.
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
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 objective of the Denver Health CVD Prevention Program is to assess the effectiveness of developing an enhanced cardiovascular disease prevention program in a community health care setting.
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.
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.
The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.
The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men.
The purpose of this research study is to find out whether a primarily self-guided program can produce changes in weight, body fat and cardiovascular risk among young men.
This study will test the preliminary efficacy of adding a very low carbohydrate dietary intervention to the evidence-based DPP-GLB on blood pressure reductions for lower-income AA men and women in a community-based clinic.
The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.
The eCMP Pilot aims to study the feasibility and potential effectiveness of an electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.
The goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. These factors include psychological distress, poor sleep quality, and exaggerated physiological responses to emotional stress. Results will be used to develop an innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating psychological distress, and attenuating stress physiology.
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.
The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.
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 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.
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 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.