Clinical Research Directory

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Implementation of Effective Hypertension Management Approaches: OSF HealthCare

The goal of this observational pragmatic study is to learn about how evidence-based interventions and best practices for management of uncontrolled hypertension can be integrated across a large healthcare system through the use of virtual and clinic-based care approaches. The primary outcome for this work is the sustained change over time in patients' reported blood pressure readings relative to guidelines-based thresholds for treatment. Measures in all domains of the RE-AIM (reach, effectiveness, adoption, Implementation and Maintenance) implementation science framework will be used.

Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.

The goal of this mixed-methods study is to assess the impact of a Community Health Worker (CHW)-led social risk screening and referral in improving management of uncontrolled diabetes (DM) and hypertension (HTN) among patients receiving care in community health centers (CHCs or health centers). The intervention is focused on adult health center patients with uncontrolled DM and/or HTN. Study findings will provide important evidence to guide CHCs in implementing programs to address social risks in their patient populations. Findings will illuminate whether and how CHW-led interventions to address social needs yield the hypothesized outcomes. The aims of the study are: * AIM 1: Measure how effective the CHW-led social risk program is at reducing blood sugar levels (A1C) in CHC patients with uncontrolled DM and lowering blood pressure in CHC patients with uncontrolled HTN. * AIM 2: Identify effective strategies for increasing and expanding CHW-led social risk programs.

Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension

Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System

This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication.

A Food Effect Study of QLS1410 in Healthy Chinese Adults

This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.

Renal Pelvic Denervation Pilot Trial

The RPD Pilot trial will evaluate the safety and effectiveness of Verve Medical's RPDTM renal denervation system for hypertensive patients with uncontrolled blood pressure despite use of two medications at a therapeutic dose. The novelty of the RPDTM system relates to its placement via natural orifice into the renal pelvis (bilaterally) for delivery of radiofrequency energy to ablate the nerves that pass through the outer wall of the renal pelvis, a technique referred to as renal pelvic denervation (RPD).

Engaging Patients in Adherence Interventions Using Behavioral Science

The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT, this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings. Accordingly, this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities. Patients will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record (EHR). The primary care clinicians of eligible patients identified through the EHR will have the opportunity to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from a preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (up to 4 calls vs. up to 2 calls). Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial. The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up, and clinical outcomes, including blood pressure as per EHR data in the 3 months after randomization.

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

The goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of single and multiple ascending doses of QLS1410 in healthy Chinese adults and participants with mild essential hypertension

Wearable Evaluation of Ambulatory Readings for Blood Pressure

The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.

Telemonitoring in Arterial Hypertension

Prospective, randomized trial to assess the effects of a telemedical approach of antihypertensive treatment in comparison with standard care. Total patient number: 60 patients. * Intervention group: biweekly telephone calls * Control group: standard of care

Remote Hypertension Management for Black Patients

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Addressing Medication Non-adherence in Patients With Poorly Controlled Hypertension Using Urine Mass Spectrometry

* Hypertension is the single largest contributor to cardiovascular disease and death. While adequate control of hypertension reduces risk of disease, many patients have uncontrolled hypertension. This is often due to medication non-adherence. Left undetected, patients are prescribed additional medications, and referred to multiple specialists for investigations - leading to increased healthcare costs. Hence, detecting non-adherence to antihypertensive medications is important. However, patient history, patient recall, or questionnaires, are often inaccurate. Most recently, urine measurements of antihypertensive drug levels, using mass spectrometry, has been established as the gold standard to assess medication adherence. The one-time urine test for medication adherence is ideal: It's convenient, non-invasive, economical, and can be easily performed in a clinic setting. By improving blood pressure control, this will lead to reductions in healthcare visits, avoidance of catastrophic cardiovascular events. Ultimately, this translates to significant economic savings for both patients with hypertension and the healthcare system. * Therefore, the investigators hypothesize that the implementation of urine adherence testing coupled with targeted counselling will improve the adherence and blood pressure control in hypertension. To do this, the investigators aim to (1) evaluate for medication adherence in 312 participants with recent stroke and hypertension; (2) evaluate for medication non-adherence in participants with uncontrolled hypertension; and (3) assess if detection of non-adherence can improve hypertension control.

An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.

SMART Study in Real World

This study is a multicenter, single-arm, open-label and post-market study in a real world patient population with uncontrolled hypertension to document the long-term safety and efficacy of a renal mapping/selective renal denervation (msRDN) system (SyMap Medical (Suzhou), Ltd, Suzhou, China) and conducted in accordance with the requirements by National Medical Production Administration (NMPA) of China. The msRDN system consists of a disposable renal artery radiofrequency ablation catheter (Registration No: National Medical Device Approval 20243011383), a console with both electronic stimulation and radiofrequency ablation function (Registration No: National Medical Device Approval 20243011384). The study includes prospective cohort and retrospective cohort. Approximately1,000 patients with uncontrolled hypertension who undergo msRDN procedure will be recruited from over 30 centers in China. Subjects enrolled in the study will be followed for at least three years after msRDN procedure. This study includes patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications per the inclusion criteria defined in the protocol.

Renal Denervation in ADPKD- RDN-ADPKD Study

RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. The purpose of the RDN-ADPKD study is to demonstrate efficacy and document safety of renal denervation (RDN) with the Paradise System in hypertensive patients with ADPKD.