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NCT04388124
The management of patients with resistant arterial hypertension, who are characterized by a very high cardiovascular risk, remains a major therapeutic issue. The use of endothelin-1 (ET-1) receptor antagonists, in addition to lowering blood pressure, may also improve endothelial function in these patients. The objective of this study is to assess the vascular impact of an ET-1 receptor antagonist on vascular function and systemic and central hemodynamics in patients with resistant arterial hypertension and ensure their good renal tolerance.
NCT06829537
This is a non-interventional study to assess the prevalence of endogenous hypercortisolism (eHC) in patients with resistant hypertension (rHTN) and will enroll approximately 1000 patients at approximately 45 sites in the United States (US). Each patient will have an initial visit for screening. After eligibility is confirmed, a limited exam will be performed and demographic and medical history will be collected. Non-fasting labs and a urine collection will also be done. A second visit will be a fasting blood draw at 8 AM after taking 1 mg of dexamethasone the night before at 11 PM. Cortisol level and study labs will also be collected. After the lab results are obtained, a third visit will be scheduled only for patients with eHC and will include a non-fasting blood draw at 8 AM and scheduling of a non-contrast CT scan.
NCT05562934
The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).
NCT07232966
The goal of this clinical trial is to investigate if focused power ultrasound (FPU) targeted perirenal adipose tissue modification therapy would be effective and safe in treating resistant hypertension. The primary outcome of the study is the difference in the reduction of 24h mean systolic blood pressure between treatment and sham procedure groups 6 months after treatment. The secondary outcomes include the reduction of clinic blood pressure 1, 3, and 6 months after treatment, the reduction of 24h mean blood pressure 1, 3, and 6 months after treatment, and the drug burden of antihypertensive treatment. The safety evaluation includes the incidence of all-cause death, cardiovascular events (stroke and myocardial infarction), renal failure, and other adverse events.
NCT07081243
The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.
NCT06940011
The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.
NCT04637152
The present study aims to evaluate the antihypertensive effect of sacubitril/valsartan in patients with resistant hypertension compared to the use of recommended and optimized antihypertensive therapy, through a randomized clinical trial, over 12 weeks.
NCT06515795
Hypertension remains the main preventable cause of cardiovascular disease (CVD) and all-cause mortality, both in Europe and globally. Resistant hypertension, a severe phenotype of hypertension, is defined as a blood pressure (BP) that remains above the management goal despite using three different antihypertensive agents of different classes at the maximum or maximum tolerated dose, or controlled BP on four or more antihypertensive medications. Hypertension remains a poorly controlled risk factor on a global scale and the prevalence of resistant hypertension is also growing - it is now estimated to be around 10-20%. At the moment, there is robust evidence establishing the antihypertensive effects of exercise. The acute reduction of BP after a single bout of exercise is known as post-exercise hypotension. In recent years, the number of investigations into the benefits of isometric exercise in the treatment of hypertension has increased, due to its ease of access and potential for use. In a recently published meta-analysis, the authors pointed to isometric exercise as the most effective type of exercise in reducing systolic and diastolic BP. Given the scarceness of data regarding the safety and efficacy of isometric exercise in individuals with resistant hypertension and since the acute response to exercise may help to identify people who respond to exercise as antihypertensive therapy, the objective of this study is to analyse the acute effect on BP levels of two different isometric exercises - isometric handgrip (IHG) and isometric wall squat (IWS), regarding safety and efficacy, in people with resistant hypertension. The aim is to analyse if isometric exercises are safe in this population, through the assessment of BP during the execution of the exercises. Besides that, the comparison of IHG and IWS with the control session and between one and another, will help to understand which form of isometric exercise is most effective and has the longest lasting impact on reducing BP. Each participant must complete an acclimatization session, in which the procedures will be explained, data will be collected and the intensity of IHG and IWS will be assessed. Subsequently, each participant must complete three randomly assigned experimental sessions: a non-exercise control session and two exercise sessions, in which they will follow the protocols currently used in the literature (IHG at 30% of Maximum Voluntary Contraction and IWS at 95% of peak Heart Rate).
NCT04519658
This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).
NCT05087940
This is a multicenter, prospective observational cohort study. It will compare effectiveness and safety of various add-on treatment options in regard to arterial blood pressure control in adult patients with treatment resistant hypertension: an aldosterone receptor blocker (e.g. spironolactone), a loop diuretic, a thiazide in large daily dose, an alpha 1 selective blocker or a beta 1 selective blocker. The add-on therapy will be prescribed to the patients within the scope of their routine medical care, independently from the study investigators. The patients will be followed up for 6 months, with monthly visits and continuous home blood pressure diary kept by the patients themselves.
NCT05247528
A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort. Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).
NCT02342808
This study will examine the effects of lifestyle intervention on fitness, dietary habits, and body weight in patients with resistant hypertension (RH). Patients will be randomized to either a 4-month adjunctive lifestyle intervention designed to lower BP that will be delivered in a center-based CR program (C-LIFE), or to standardized education and physician advice (SEPA) designed to promote the same healthy behaviors and reflecting the current highest possible standard of care for promoting a healthy lifestyle in RH.
NCT04213963
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.
NCT03317951
Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices). The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.
NCT02670681
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.
NCT02926495
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.
NCT01874470
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
NCT00272961
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.