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The aim of this study was to evaluate the therapeutic effect of sodium intake reduction by education in patients with resistant hypertension. The study was designed to maximize the compliance to antihypertensive agents and use optimal doses of antihypertensive agents including diuretics for 2 months before randomization. Patients will be assigned randomly to receiving (1) education of sodium intake reduction and exercise, or (2) education of exercise alone. Education of sodium intake reduction will be blinded to patients, and education of exercise will be provided to both group to blind the subjects. Daytime ambulatory blood pressure is adopted for diagnosis of resistant hypertension to avoid white-coat effect.
This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.
The main purpose of this study is to assess whether exercise training reduces ambulatory blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients with resistant hypertension will be recruited and randomized into exercise training or control groups and followed up for 6 months. The patients in the exercise group will participate in a 3-month outpatient program. The control group will receive usual medical care. At baseline, after the intervention and 3 months after the end of the intervention both groups will undergo several evaluations, including casual and ambulatory blood pressure, body composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic function, and endothelial and inflammatory biomarkers.
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. While most treated individuals with hypertension are controlled on medication, diet and exercise, an estimated 12% are resistant to conventional medical intervention. Alternative effective treatments are still needed for this hypertensive patient population to mitigate the risk and incidence of mortality and morbidity. This original Investigational Device Application is for a study intended to confirm the safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to the median nerve from a small coin sized device placed under the skin of the distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New Zealand, Taiwan and Canada. This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted subcutaneously in the right and left forearms of patients with uncontrolled hypertension despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing period, subjects will be 1:1 randomized into either a treatment or control group. One half of the subjects have their devices activated (treatment) and the other half undergo a sham activation (control) to maintain participant blinding to their treatment allocation. During the six months post-randomization, the eCoin is ON in the treatment group and OFF in the control group.
The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. After, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. In both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.
Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted. Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy. Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension. Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study. This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria. The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.
The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.