31 Clinical Trials for Various Conditions
The purpose of this study (PASSION study) is to monitor symptoms of chronic pain before and after 2 weeks of a standard drug commonly used to treat elevated blood pressure compared with 2 weeks of placebo (crossover design) so that we may better understand how blood pressure affects your level of pain. This study is not testing an experimental drug.
The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model \[called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction\] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.
The primary aim is to identify the impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) at 6 months, via a randomized controlled trial.
This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure.
The primary aim is to evaluate impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care control on systolic blood pressure at 6 months, via a randomized controlled trial.
Specific aims are: 1. To outline and evaluate key active elements of the Mindfulness-Based Blood Pressure Reduction (MB-BP) intervention. This aim will be achieved using (a) focus groups of participants undergoing the MB-BP intervention, (b) discussion with experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness intervention instructors) prior to, and following pilot testing of MBHT in participants, and (c) clinical judgment of the investigators performing the intervention. 2. To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and longevity of target engagement (follow-up time-points). Follow-up time periods include 10 weeks, 6 months and 1 year. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design to further evaluate causation and effect size.
The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic designed for stroke patients and was established to provide a comprehensive approach to stroke risk factor reduction. The goal of this study will be more effective than usual care at reducing blood pressure in patients with poorly controlled blood pressure after an ischemic or hemorrhagic stroke or transient ischemic attack.
The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.
High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.
Obesity is a serious health problem that is a contributing factor for heart disease and high blood pressure. This study will evaluate a lifestyle modification program that aims to encourage weight loss and improve the health of people with high blood pressure from low income and minority communities.
Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order to reduce blood pressure. It is not known if the body compensates over time to the blood pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a faster rate and is higher than it was at the start of the treatment. This study will answer these questions.
To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.
This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).
This study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.
To assess the effect of sodium-glucose cotransporter 2 (SGLT-2) inhibitors on blood pressure and urinary angiotensinogen. This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6 weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an open label as a comparative to the cross over subjects to assess if the effect of Dapagliflozin may also be in part due to improved glycemic control.
Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of both maternal and fetal complications of pregnancy. To date, there is no known "cure" for preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure, and may be easier to perform in a pregnant population, leading to higher compliance. The investigators propose to perform a novel prospective study of a resistance training regimen on blood pressure in pregnant patients at high risk for developing preeclampsia or high blood pressure.
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
Nearly 60 million adults in the United States have high blood pressure (BP) in the pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8 deaths in the world, and in the US the direct and indirect costs of high BP are estimated to reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for prehypertension, followed by antihypertensive medication if BP progresses to Stage I hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions. Some stress management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP. When added to lifestyle modification advice, MBSR may be an appropriate complementary treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR for prehypertension and/or hypertension, pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility. This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect. Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework. Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.
This study will examine the effects of two behavioral stress reduction programs, mindfulness meditation (MM) and the lifeskills program (LP), and a health education control program (CTL) on blood pressure.
The proposed study investigated the effect of chronotherapeutic alteration of anti-hypertensive medication on nocturnal hypertension and end-organ injury in pediatric renal transplant recipients who are non-dippers. Additionally, the investigators examined the association between response to intervention, serum adiponectin levels and adiponectin gene polymorphisms. The investigators hypothesized that (1) evening administration of anti-hypertensive medication will convert subjects from non-dipper to dipper status, improve mean nocturnal blood pressure (BP), and improve nocturnal BP load, (2) evening administration of anti-hypertensive medication will reduce albuminuria, left ventricular mass index (LVMI), rate of decline of glomerular filtration rate (eGFR) and will decrease pulse wave velocity (PWV).
This clinical trial aims to evaluate whether a calming virtual reality (VR) experience can reduce office blood pressure (OBP) and anxiety in adults undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic in Florida. The main questions it aims to answer are: 1. Does a 5-minute calming VR session reduce office blood pressure in patients with suspected white coat hypertension or white coat effect? 2. Does VR exposure reduce self-reported anxiety levels in the clinical setting? 3. Does VR reduce the difference between home (ABPM) and clinic blood pressure readings? Participants will: 1. Complete two short electronic surveys (before and after VR exposure) on a clinic-provided device. 2. Undergo a 5-minute virtual reality (VR) relaxation session. 3. Have their blood pressure measured before and after the VR session. Participation will occur during the participant's scheduled ABPM device return visit and will add approximately 30 minutes to the visit. This is a single-arm, pre-post interventional study where each participant serves as their own control.
Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
The purpose of the research is to evaluate the feasibility and scalability of delivering a 30-minute novel virtual reality (VR) experience through the Oculus Quest 2 Virtual Reality headset with the aim of measuring changes in: 1) patient-reported stress levels on a survey, 2) blood pressure, 3)heart rate, 4) respiration rate 5) heart rate variability 6) and galvanic skin response in cardiology clinic and cardiac rehabilitation patients.
Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both. After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure \<140 and diastolic blood pressure \<90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups. Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results. The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling.
There is emerging evidence that an excessive amount of sitting is linked with an increased risk of negative health outcomes independent of an individual's physical activity levels. This is concerning considering data indicate Americans spend over half of the waking day engaged in sedentary activities, and that individuals who are overweight or obese and/or have a chronic disease such as hypertension are likely to have an even higher level of sedentary behavior. A limited number of experimental studies have looked at the effects of reducing sitting time on blood pressure and have shown promise. However, these studies lasted for only a day, so it is unclear how reducing sedentary time may influence blood pressure over a longer duration. The purpose of this study is to look the relationships between the amount of time a person spends sitting and their blood pressure and examine whether decreasing sedentary behavior helps improve blood pressure. The study employs the use of coaching calls and a mobile health (mHealth) intervention to reduce the sedentary behavior of participants through strategies such as prompting, feedback, and counseling.
Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects of aerobic exercise training and intensive vascular risk reduction on cognitive performance in older adults who have high risk for AD.
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.
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.