Blood Pressure Clinical Trials

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems. Read Less

The overarching goal of the proposed study is to develop and test an enrichment to Nurse-Family Partnership (NFP) using an existing, evidence-based program to improve clients' and their children's cardiovascular health from early pregnancy to 24 months postpartum. With support from NFP supervisors and nurses, the investigators will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. The investigators will conduct a pilot study with up to 40 NFP clients (or women similar to NFP client population) and their nurses to determine feasibility and acceptability of the materials and study protocol. Read Less

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery. Read Less

Brief Summary: Black adults have a higher incidence of hypertension (HTN) and a greater risk of HTN-related cardiovascular disease (CVD) compared with White adults. Even mild elevations in blood (BP) above 115/75 mm Hg are associated with increased CVD risk. Accordingly, emphasis is being placed on early interventions for high BP, particularly in those who are low cardiovascular risk(systolic BP 110-139 and diastolic BP < 90 mm Hg), for participants lifestyle modification is recommended. Although lifestyle modifications are effective to lower BP, implementation is suboptimal in Black communities, especially those participants residing in low-income urban settings. Pervasive negative social determinants of health (SDoH), such as poor access to healthcare, food insecurity, limited availability of healthy foods, lack of safe places to engage in physical activity, and low health literacy are major drivers of inequities in HTN and a critical barrier to implementation of recommended lifestyle modifications in Black communities. To achieve health equity, effective strategies must address negative SDoH that are root causes of racial disparities in health outcomes as clearly demonstrated by the coronavirus disease (COVID-19) pandemic. Predominantly Black cities like Detroit, Michigan, where the mortality rate from heart disease is nearly twice the national average, have been devastated by COVID-19. To address this, the investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct deployment of testing and vaccination services to communities with highest needs. Since April 2020, the investigators conducted 500 events with 220 community partners where 40,000 people have been tested or vaccinated for COVID in MHUs. Using a hybrid type I effectiveness-implementation design in the proposed Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study, the investigators will implement a novel approach that links low cardiovascular risk Black adult participants without stage-2 hypertension to collaborative care delivered in deprived neighborhoods by community health workers (CHWs) using a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention. The investigators will leverage our MHU program, layering on top of existing services to streamline access for screening, recruitment and all ongoing follow-up throughout the study period. Our specific aims are: AIM 1: To compare the effect of PAL2 intervention versus usual care (MHU engagement without PAL2) on systolic BP reduction and prevention of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP >90 mm Hg) among 500 Black adults with baseline untreated systolic BPs below stage 2 (ranging 110-139 mm Hg) and a diastolic BP < 90 mm Hg. Hypothesis (H) 1a: Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months. H1b: Diastolic BP levels and the incidence of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP >90 mmm Hg) at 6 and 12 months (secondary outcomes) will be lower in participants randomized to the PAL2 intervention versus usual care. AIM 2: To use the RE-AIM framework to assess the reach, adoption, effectiveness, sustainability and cost of LEAP-HTN at 12 months post-randomization. H2a: The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and up to 24 months in subjects with available data, respectively. H2b: PAL2 intervention will be more cost-effective than usual care at 12 months and projected to be more cost-effective at 10 years. Health Equity Impact: Targeted deployment of MHUs and PAL2 can mitigate several key adverse SDoH. LEAP-HTN contributes to the RESTORE Network by testing a sustainable and scalable approach to advance health equity and prevent HTN in Black adults participants. If successful, the use of MHU can be easily implemented in similar urban Black communities across the U.S. Read Less

This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This study is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of our target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. Another aim is to examine the feasibility and acceptability of delivering the CSSP after tailoring the proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama. Read Less

Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold. Read Less

This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous (IV) vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain continuous data acquisition (CDA). The investigators will explore BP change based on electronic medical record (EMR) vs CNS-200 data. This study will consent and observe 30 Neuroscience Intensive Care Unit subjects using pragmatic sampling. Each subject will be observed one-and-only-one time for a 12-hour period. Read Less

To compare a noninvasive and continuous radial artery blood pressure measurements utilizing ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in patients undergoing surgery or those who are being cared for in the intensive care unit Read Less

This randomized, parallel-design trial will evaluate specific clinical and physiological effects of whole blueberries in adults 70 years of age or older. Read Less

The Potassium Intake-response Trial to Control Hypertension (PITCH) will test the intake-response relationship between potassium supplementation and blood pressure, which may inform clinical guidelines on the optimal level of potassium supplementation for blood pressure lowering among adults with elevated blood pressure or hypertension and dietary guidelines for population intake. Read Less

This study has two phases: Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers Read Less

High blood pressure (BP) is the major modifiable risk factor for cardiovascular diseases (CVD) and related health conditions, particularly among postmenopausal (PM) women. In adults age ≥50 years this risk is primarily driven by above-normal systolic BP (SBP ≥120 mmHg), as diastolic BP plateaus, then decreases in older adulthood. Although SBP is lower in premenopausal women vs. age-matched men, SBP reaches, then surpasses men after age 60. As such, >75% of PM women in the U.S. have above-normal SBP, which, in turn, is responsible for a 2-fold increase in risk of hypertension and corresponding increases in risk of CVD, chronic kidney disease and many other disorders. A key process linking high SBP to CVD and related conditions is vascular endothelial dysfunction, mediated by excessive reactive oxygen species (ROS)-induced oxidative stress and reductions in nitric oxide (NO) bioavailability. As the number of PM women is rapidly growing, further increases in SBP-related CV disorders are projected without effective intervention. Aerobic exercise (AE) is a first-line, standard-of-care therapy for lowering BP. In PM women with baseline SBP ≥120 mmHg, AE reduces casual (resting) SBP by ~3 mmHg (back to baseline ≤4 weeks post-training), whereas 24-hour SBP is typically unchanged. However, only 25-30% of PM women meet guidelines for 150 min/week of moderate-intensity AE, citing the extensive time requirement, facility access and travel disruptions as major barriers. Another, far less recognized, limitation is that AE training consistently improves endothelial function in midlife/older men, but not in estrogen-deficient PM (PMe-) women, i.e., in >95% of the 60+million PM women in the U.S. Thus, establishing new lifestyle therapies that induce and sustain reductions in SBP and increases in endothelial function in PMe- women with above-normal SBP is an important public health goal. High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. In addition, IMST improved endothelial function in the PMe- women in a small pilot study. To translate these promising preliminary results towards clinical practice, this randomized clinical trial is being conducted to directly compare the efficacy of a longer, clinically relevant treatment duration of IMST (3 months) against home-based, moderate-intensity (standard-of-care) AE in PMe-women. The primary outcome will be the change in casual SBP (IMST vs. AE). Changes in 24-hour SBP and endothelial function will serve as secondary outcomes. Effects on NO bioavailability, ROS/oxidative stress, and the role of "circulating factors" will provide insight into mechanisms of action. The sustained effects on SBP and endothelial function also will be assessed. Accordingly, a randomized, blinded, sham-controlled, parallel group design clinical trial will be conducted to assess the efficacy of 3-months of IMST (75 percent maximal inspiratory pressure) vs. brisk walking (40-60% heart rate reserve; an established healthy lifestyle strategy) for lowering SBP and improving endothelial function in PMe- women age 50 years and older with above-normal SBP. It is hypothesized that IMST will lower SBP and improve endothelial function by decreasing oxidative stress and increasing nitric oxide bioavailability. It is also expect that adherence to the intervention will be excellent (over 80 percent of all training sessions completed at the appropriate intensity). To test this hypothesis, 90 PMe- women age 50 years and older who have SBP >/= 120 mmHg will be recruited. Participants will undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP and endothelial function. Innovative mechanistic probes including pharmaco-dissection with vitamin C, analysis of biopsied endothelial cells, and high-throughput metabolomics, will be performed to assess oxidative stress and nitric oxide bioavailability at baseline. After baseline testing, subjects will be randomized to perform either 3-months of high-resistance IMST or brisk walking. Subjects will train 6 days/week. Following 3 months of training, subjects will redo all the tests that were done during baseline testing to assess training-induced changes in SBP, physiological functions, and underlying mechanisms. Subjects will then cease training for 6 weeks before returning to the lab for follow-up testing to determine the persistent effects of IMST. Read Less