View clinical trials related to Blood Pressure.
Filter by:This study will employ a randomized mixed between-within experimental stress-testing protocol design. Physiological responses (blood pressure and pulse) will be recorded throughout a baseline, gratitude induction, standard stress-task and recovery period. Participants will be randomly allocated to the experimental (grateful induction) or control condition (neutral induction). Gratitude will be induced by completing a gratitude letter. Demographics will be measured. Psychosocial and health variables will be measured psychometrically at baseline to assess pre-existing levels and after both manipulations (allocated induction and stress task) to monitor expected change over time between conditions. Stress task is an adapted version of the Trier Stress Testing protocol.
The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health & Hospital System.
A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.
Previous studies have shown that elevated nighttime blood pressure (BP) was more closely associated with cardiovascular mortality and morbidity than daytime and clinic BPs. With increasingly advanced technology, not only 24-hour ambulatory but also home BP monitors can be used to evaluate nighttime BP. The validation study of the Omron HEM 9601T showed that the wrist-type home BP monitor could be a suitable and reliable tool for the diagnosis and management of nocturnal hypertension. However, up to now, there is no data on home nighttime BP in Chinese patients and it is unclear if different dosing time would reduce ambulatory and home nighttime BPs differently. The investigators therefore designed a multicenter randomized clinical trial to compare between morning dosing and bedtime dosing of antihypertensive medications in the difference in nighttime, daytime and the 24-h BP reductions evaluated by both ambulatory and home BP monitoring, and in target organ protections.
The study's objective is to assess whether CAM methods are feasible and beneficial in the WSRH setting; to assess stress (using the Perceived Stress Scale-14 and using BioSquares™), anxiety (using the Generalized Anxiety Disorder-7 scale), depression (using the Patient Health Questionnaire-9 scale), pain (using the Wong-Baker FACES scale), and vital signs using a multidisciplinary complementary approach with Heartfulness Meditation, Conscious Breathing, and Emotional Freedom Technique - the CAM practices for this study; and, to assess and compare the above scores for each participant just prior to and immediately after each treatment session. The study hypothesizes that using CAM modalities in the WSRH is both feasible and beneficial in that patient population; the patients receiving the CAM modalities of treatment will show an improvement in the above-mentioned scores compared to participant scores prior to the intervention; and there may also be an improvement in patients' vital signs following the intervention of CAM practices.
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.
The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in people living with HIV (PLWH). The study will recruit 960 PLWH across 30 primary health centers (PHCs) in Akwa Ibom State (32 patients/PHC).
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure. This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
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.
The goal of this study is to determine the impact of dietary sodium and fructose on blood pressure and inflammation in young healthy adults.