22 Clinical Trials for Various Conditions
The investigators working hypothesis is that human hypertension is in part due to a derangement in the endocrine function of the heart - a primary or secondary mechanism - resulting in a relative deficiency of the natriuretic peptides (NP). The remodeled hypertensive heart could result in altered processing and degradation of B-type NP resulting in altered molecular forms with decreased biological activity. The investigators further hypothesized the chronic administration of BNP in subjects with hypertension, is feasible, safe and will induce a sustained reduction in blood pressure.
This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.
The goal of this clinical trial is to determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals. The main questions it aims to answer are (1) if boxing training reduces peripheral and central blood pressure and (2) if boxing training improves cardiovascular function in elevated blood pressure or hypertension stage 1 individuals. Participants with elevated blood pressure or hypertension stage 1 will be randomly divided into a control group or an intervention group. The latter group will be involved in boxing training, 3 days per week for 6 weeks. Researchers will compare clinical and cardiovascular outcomes between the control and the intervention group.
In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P \<0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.
To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure.
Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness. The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.
To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.
Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.
This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated or Stage 1 hypertension.
The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of cocoa-containing product consumption over an 8-week period and assess effects on blood pressure, endothelial function and arterial stiffness. The randomized, controlled, modified Latin square parallel design will compare the effects of two doses of cocoa consumption on blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1 hypertension.
Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the Relaxation Response may lead to improvement in-or normalization of-these factors. By studying the impact of the Relaxation Response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore, with a greater understanding of the physiologic mechanisms by which the Relaxation Response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.
The purpose of this study is to determine that effects of an intervention called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage 1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg / hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.
This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension. The secondary objectives of the study are to characterize the pharmacokinetic profile of single ascending doses of Vasomera and the relationship between serum concentrations of Vasomera and change in systolic and diastolic blood pressure as measured by: * Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) as compared to placebo. * Identification of the minimum and maximum decrease in systolic and diastolic blood pressure as measured by ABPM. * Mean change from baseline in cuff systolic and diastolic blood pressure as compared to placebo. * Effect of Vasomera on pulse pressure and heart rate. An additional secondary objective of this study will be to characterize the immunogenicity profile of Vasomera following a single subcutaneous dose.
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (\<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (\<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
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 purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.
The purpose of this randomized clinical trial is to learn if 'complex' cancer patients who receive care guided by a health system intervention, Primary Care Connect (PC2) have their risks of cardiovascular disease (CVD) managed better than those who receive usual care. This study focuses on "complex" cancer survivors who have higher CVD risk when diagnosed with cancer because they also have had a diagnosis of 1 or more chronic conditions (e.g., hypertension, diabetes, and/or hyperlipidemia) requiring medication management. This study also aims to learn about the ease of implementing the health system intervention from the perspectives of cancer teams, primary care teams, and complex cancer patients. The main questions the study aims to answer are: * Do patients enrolled in the PC2 arm remain connected to their primary care teams during active cancer treatment for chronic disease management compared to patients in usual care? * Do patients enrolled in the PC2 arm have better management of their chronic conditions during active cancer treatment compared to patients in usual care? * How do the care team and patients experience this change in care delivery related to their work and care experiences? This study will compare complex cancer survivors who receive care according to the PC2 intervention to usual care to see if PC2 works to improve cardiovascular risk management. Participants will: * receive educational materials about the study upon enrollment * complete on-line or written surveys at 4 times * Visit the clinic for check ups and test related to the study 4 times
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.