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Essential Hypertension clinical trials

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NCT ID: NCT04406129 Recruiting - Hypertension Clinical Trials

Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT

FMT
Start date: March 17, 2021
Phase: Early Phase 1
Study type: Interventional

Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This pilot study will utilize fecal microbiota transplantation (FMT) capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome restoration on primary hypertension.

NCT ID: NCT04403347 Recruiting - Hypertension Clinical Trials

Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention

Start date: July 8, 2021
Phase: Early Phase 1
Study type: Interventional

Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut microbiota on the pathogenesis of primary hypertension. Dietary changes appeared to reshape gut microbiota and to ameliorate diseases such as Type 2 Diabetes. A hypothesis is thus raised that dietary changes can be a potential approach to ameliorate hypertension via gut microbiome restoration. This pilot study will utilize an innovative natural dietary formulation (patent ID: CN110250417A), in comparison with classic antihypertensive treatment (losartan 50mg per day) and usual care (guideline-based patient education and lifestyle recommendations), to investigate its effect and safety on primary hypertension treatment, and the underlying mechanisms of gut microbiome restoration.

NCT ID: NCT04103411 Recruiting - Clinical trials for Hypertension,Essential

Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure

DIISCCO
Start date: April 26, 2018
Phase: N/A
Study type: Interventional

The number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. This protocol will determine if HIIT is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (BP) in prehypertensive older adults.

NCT ID: NCT03945305 Recruiting - Clinical trials for Essential Hypertension

Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

NCT ID: NCT03928158 Recruiting - Heart Failure Clinical Trials

LCZ696 in Advanced LV Hypertrophy and HFpEF

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

Patients with advanced LVH and HFpEF will be randomly assigned in open-label fashion to receive LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily, and will be treated for 24 weeks.

NCT ID: NCT03928145 Recruiting - Hypertension Clinical Trials

Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension.

Start date: November 13, 2019
Phase: Phase 3
Study type: Interventional

Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.

NCT ID: NCT03858595 Recruiting - Clinical trials for Hypertension in Pregnancy

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Background: 1. Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences. 2. Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management. 3. Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible. Objectives: 1. To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure. 2. To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy. Methods: The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy. Outcome measures/variables: 1. Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc. 2. Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy 3. Serious adverse events

NCT ID: NCT03857490 Recruiting - Clinical trials for Essential Hypertension

Heat Therapy in Older Hypertensive Women

Start date: July 29, 2019
Phase: N/A
Study type: Interventional

The prevalence of hypertension is greater in older women than men, while the blood pressure (BP) control rate is lower in older women in US. Uncontrolled hypertension is a major risk factor for cardiovascular morbidity/mortality. Despite standard therapy and adherence to optimal drug regimens, >50% of older hypertensive women still have inadequate BP control, and the control rate is further reduced with more aggressive BP targets recommended recently by the new Hypertension Guidelines. Thus, the effectiveness of drug treatment alone in the control of hypertension among older women is limited; hence, non-pharmacological approaches are also needed to help reduce BP in older hypertensive women. One adjuvant, non-pharmacological approach that offers promise in lowering BP is "heat therapy". Indeed, repeated whole-body heat exposure decreases BP in healthy humans. Whether this is also true after regional limb heating in hypertensive patients is unknown. The objectives of this research are to investigate the BP lowering effect of home-based lower leg heat therapy in older women with hypertension, and to examine the impact of this therapeutic modality on neural-vascular health in these patients. Aim 1 will test the hypothesis that chronic lower leg heat therapy combined with an antihypertensive drug is superior to drug treatment alone in lowering BP in older hypertensive women. We will randomly assign older hypertensive women to either an intervention group or a control group. Patients in the intervention group will perform 8 weeks of lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times/week, 45 min/session), whereas patients in the control group will immerse their legs in a thermoneutral water bath (33°C) at the same frequency and duration. All patients will also receive a fixed dose of chlorthalidone (a diuretic, 25 mg orally daily). We will compare ambulatory BP, the BP control rate, and patient adherence and acceptability to treatment between the groups. Aim 2 will test the hypothesis that chronic lower leg heat therapy will improve nitric oxide bioavailability which can decrease sympathetic vasoconstriction and improve vascular function in older hypertensive women. We will use state-of-the-art techniques of microneurography, Doppler ultrasound, applanation tonometry, and cutaneous microdialysis to assess neural control, vasodilator function, and interstitial metabolites (i.e. nitrate and nitrite) indicative of basal nitric oxide bioavailability in all patients enrolled in Aim 1 before and after 8 weeks of heat therapy. Information obtained from this research project will guide evidence-based clinical practice. It is anticipated that our study may lead to revision of hypertension guidelines to incorporate home-based heat therapy as adjuvant to antihypertensive drug(s) for older women, as well as other patient populations.

NCT ID: NCT03708601 Recruiting - Clinical trials for Essential Hypertension

Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)

Start date: September 8, 2016
Phase:
Study type: Observational

The registry study aims to determine serial biomarkers to prognosis of Essential Hypertension

NCT ID: NCT03566654 Recruiting - Clinical trials for Essential Hypertension

Clinical Trial on Remote Ischemic Conditioning and Hypertension(HOPE)

Start date: August 30, 2018
Phase: Phase 2
Study type: Interventional

Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has became a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and decrease of 1~3mmHg will reduce the stroke risk by 20~30%. As to diastolic pressure, 5mmHg decrease of it will reduce the stroke risk by 34% and 10mmHg decrease of it will reduce the stroke risk by 56%. In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140~159mmHg, DPB< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension Management Guidelines of standard of diagnosis for hypertension and timing of starting medical treatment in hypertensive patients.Because more and more reseaches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than 120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have blind spot in treating such patients who suffer from borderline systolic hypertension at 130~140 mmHg of blood pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have stroke, it would lead terrible and costly consequences to both their family and the society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke.