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Hypertension clinical trials

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NCT ID: NCT03604289 Terminated - Obesity Clinical Trials

Angiotensin 1-7 in Obesity Hypertension

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to find out if the investigational drug angiotensin-(1-7) improves cardiovascular health in patients with obesity and high blood pressure.

NCT ID: NCT03595982 Terminated - Clinical trials for Hypertension in Pregnancy

Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?

Start date: September 15, 2018
Phase: Phase 4
Study type: Interventional

Antihypertensive therapy has been used in pregnant patients antepartum to improve blood pressure (BP) elevation in cases of chronic hypertension, and postpartum for persistent hypertension after delivery in cases of gestational hypertension and preeclampsia, as well as for management of chronic hypertension. There is limited evidence regarding the precise BP level at which antihypertensive therapy is indicated during pregnancy for chronic hypertension. Treatment has been suggested in pregnant patients when systolic BP is ≥ 160 mmHg and at a lower diastolic BP threshold of 105 mm Hg, however some providers may initiate therapy at systolic BPs ≥ 150 mmHg. Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile. It has been proven to be safe in pregnancy. Conventional nifedipine can be started at 10 mg twice daily with a maximum dose of 120 mg/d, but frequently extended release tablets are preferred due to steady blood pressure control with once daily administration. It is frequently used however as a twice daily dosing as many providers have noticed an increase in the BPs 12-24h from administration. Twice daily dosing might produce overlapping profiles that prevent elevation of BP at the time of the next administration and breakthrough elevations throughout the day in pregnant women. The aim of this study is to investigate the mean plasma levels and standard deviations of Procardia at 24h after Procardia XL is administered as a 60 mg daily dose and the mean plasma levels after it is given as a 30 mg twice-daily dose. This will be a pilot study for a future randomized control trial that will allow the researchers to determine whether 60 mg daily of Procardia XL is equivalent to 30 mg twice daily. Secondary outcome will be effective control of BP throughout the day (0h, 4h, 8h, 12h, 16h, 20h and 24h) defined as BPs below 160/105 as well as side effects of nifedipine as reported by patients.

NCT ID: NCT03592355 Terminated - Stroke Clinical Trials

Virtual Visits at Brigham and Women's Hospital

Start date: April 13, 2018
Phase: N/A
Study type: Interventional

Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). The investigators plan to enroll no more than 200 clinicians. Any clinician in a department selected by the Brigham Health Virtual Care team for access to virtual visits is eligible, unless s/he saw less than 20 patients monthly over the last 6 months. The Brigham Health Virtual Care team will onboard all clinicians and provide virtual visit support as per their usual protocol. The primary study endpoint is third-available appointment, a well-adopted measure of access. Other secondary endpoints revolve around continuity, efficiency, utilization, safety, cost, and patient experience.

NCT ID: NCT03590860 Terminated - Hypertension Clinical Trials

A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)

Start date: July 13, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety of the study drug known as LY3322207. Participants must be healthy or must have hypertension (high blood pressure). Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).

NCT ID: NCT03556020 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH

VIP
Start date: July 15, 2018
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of pemziviptadil (PB1046) at the optimally titrated dose after 16 weeks of treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose groups: a) high-dose group where PB1046 will be up-titrated from a 0.2 mg/kg minimally effective starting dose to a target high dose level of at least 1.2 mg/kg or higher to a maximally tolerated dose (MTD), or b) a low-dose group that will start at 0.2 mg/kg and remain at this minimally effective dose (MED) level with sham up-titration. The total treatment period will be comprised of 2 phases: 1) an initial 10 week dose titration phase in which weekly doses of PB1046 will be titrated (or sham titrated) up to a target dose level of at least 1.2 mg/kg or higher to the MTD, and 2) a maintenance of treatment phase that begins when subjects reach week 11 and continues for 6 weeks during which no further up-titration should occur.

NCT ID: NCT03551119 Terminated - Clinical trials for Chronic Kidney Diseases

Physical Activity in Renal Disease (PAIRED): The Effect on Hypertension

Start date: November 21, 2018
Phase: Phase 3
Study type: Interventional

Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Exercise is an effective strategy for blood pressure (BP) reduction in the general population but in people with CKD, hypertension is mediated by different causes (i.e. vascular stiffness, volume expansion) and it is unclear whether exercise will reduce BP in this population. Consequently, exercise resources are not offered in the routine multidisciplinary care of people with CKD and the prevalence of sedentary behaviour remains double that of the general population. The role of exercise in CKD management is also an important question for patients. From CIHR-supported workshops with patients, the role of lifestyle, such as exercise in CKD was a top research priority. Research aims: i.To determine the effect of exercise on mean ambulatory systolic blood pressure (SBP) in people with CKD compared to usual care. The investigators hypothesize that exercise training will significantly reduce BP compared to control. ii.To inform the design of a larger, multi-center trial evaluating the effect of exercise on the risk of CKD progression. Methods: A 160 participant, single center randomized trial of adults from Alberta Kidney Care North CKD clinics, Edmonton, Albert, Canada. Participants with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min per 1.73m2 and SBP >130 mmHg will be randomized, stratified by eGFR (<30 versus ≥ 30) to an exercise intervention or usual care. The main outcome is the difference in 24-hour ambulatory SBP after eight weeks of exercise training between groups. Secondary outcomes include: BPs at eight and 24 weeks, dose of anti-hypertensives, aortic stiffness, CV-risk markers, CV fitness, 7-day accelerometry, quality of life, safety, and in an exploratory analysis, eGFR and proteinuria. The intervention is thrice weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise, targeting 150 minutes per week and delivered over 24-weeks. Phase 1: one supervised weekly sessions and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). To detect a clinically important BP reduction of 5 mmHg between groups requires 128 patients (two sample t-test, alpha 0.05, beta 0.2, common standard deviation of 10 mmHg). Assuming 20% dropout requires 160 patients. For the primary outcome, the investigators will use a mixed linear regression model in which BP is regressed on group, baseline SBP and eGFR, and time point. Expected outcomes: The findings from this study will address a significant knowledge gap in hypertension management in CKD, inform care-delivery and the design of a larger study on CKD progression. This proposal aligns with priorities for both patients and decision makers: to identify the role of exercise in CKD management and to reshape the delivery of renal care so that it is more consistent with patient values and preferences.

NCT ID: NCT03542812 Terminated - Clinical trials for Pulmonary Hypertension

L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia

Start date: July 30, 2019
Phase: Early Phase 1
Study type: Interventional

Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g). Based on the current numbers of VLBW infants born annually in the U.S., between 5,000-10,000 neonates will develop BPD each year. It is estimated that 8-42% of infants with BPD will develop pulmonary hypertension (PH). Moreover, it has been known since the 1980's that echocardiographic evidence of PH in infants with BPD is associated with up to 40% mortality. Treatment options to ameliorate PH in infants with BPD (BPD-PH) are limited. There have been no randomized clinical trials of any therapy in infants with BPD-PH. The standard care for the management of BPD-PH is to attempt to resolve the underlying lung disorder and the judicious use of oxygen as a potent pulmonary vasodilator. Using this management approach, which has not changed since the 1980's, the survival rates for infants with BPD-PH in the 2000's has been reported to be 64% at 6 months and 53% at 2 years after diagnosis of PH. The lack of improvement in outcomes for the past 3 decades has led to the widespread agreement that novel and effective therapies are desperately needed for infants with BPD-PH. The goal is to develop oral L-citrulline clinically for the treatment of pediatric pulmonary hypertension associated with bronchopulmonary dysplasia (BPD-PH); before pursuing a large scale treatment trial, pharmacokinetic (PK) dose-finding, tolerability studies in patients at high risk of developing BPD-PH are warranted. The hypothesis is that oral L-citrulline will be well tolerated, without significant adverse effects in infants at high risk of developing pulmonary hypertension (PH) associated with BPD. The investigators propose to first characterize the PK profile of oral L-citrulline in order to define an appropriate dose range and treatment interval for infants at high risk of developing BPD-PH. Then using the doses and intervals generated by the PK profile, with a maximum dose of 3 g/kg/d, the investigators propose to evaluate the tolerability and ability to achieve the target study drug level (100-150 micromolar) in babies treated for 72 hours with oral L-citrulline. These studies will provide the data needed to design a full-scale randomized multi-center trial to evaluate the efficacy of oral L-citrulline therapy to ameliorate BPD-PH in human infants, a patient population that has a desperate need of new therapies.

NCT ID: NCT03529838 Terminated - Hypertension Clinical Trials

Hemodynamic and Salivary Responses of 12 Weeks of Training With Different Anti-hypertensive

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.

NCT ID: NCT03515005 Terminated - Hypertension Clinical Trials

Using Lay Health Advisors to Improve Hypertension Management

Start date: December 3, 2018
Phase: N/A
Study type: Interventional

Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.

NCT ID: NCT03501966 Terminated - Clinical trials for Idiopathic Intracranial Hypertension

Surgical Idiopathic Intracranial Hypertension Treatment Trial

SIGHT
Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.