Clinical Research Directory

A Phase Ⅱ Clinical Trial Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients

SYH2072 is a highly selective aldosterone synthase inhibitor. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of SYH2072 tablets in patients with uncontrolled hypertension (including patients with resistant hypertension) receiving stable treatment with two or more antihypertensive agents.

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

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension

Primary aldosteronism (PA) is common but rarely recognized cause of hypertension that carries excess cardiovascular and renal risk and has approved targeted treatments. Despite current clinical guidelines that recommend screening in a defined set of high-risk populations, less than 5% of eligible patients are ever screened for PA. This study aims to evaluate the impact of a computer decision support Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients, referral to specialist PA care, and treatment with mineralocorticoid receptor antagonists.

JX09 SAD/MAD in Healthy Participants

This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.

Heart Rate Variability and Medication Adherence in Resistant Hypertension

This single-center, cross-sectional observational study examines the relationship between adherence to antihypertensive therapy - verified objectively by therapeutic drug monitoring (TDM) - and heart rate variability (HRV) in patients with resistant hypertension. Patients are recruited opportunistically, in a nurse-led manner, in a one-day-care cardiology unit, and undergo a single examination: a short-term HRV recording (Polar H10), a single blood draw for antihypertensive drug levels, office blood pressure, and self-completed questionnaires. There is no follow-up.

Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension

Many patients on hemodialysis have high blood pressure that does not respond to three or more drugs (resistant hypertension). This pilot study gave a low dose of spironolactone (12.5 mg once daily) for 6 weeks to adults on hemodialysis with resistant hypertension. The study measured changes in blood pressure, heart rate variability, markers of inflammation (interleukin-6 and high-sensitivity C-reactive protein), a marker of cardiac stress (NT-proBNP), and serum potassium.

Prevalence, Clinical Characteristics and Treatment of Bulgarian Patients With Resistant Hypertension

Study objectives: Our study aimed to assess the prevalence, characteristics, and treatment of patients with resistant hypertension (HTN) in Bulgarian hypertensive population. Methods: We screened 4340 consecutive cardiovascular patients hospitalized in our clinic and identified 3762 with HTN. Of them, 128 fulfilled the current (2018) European Society of Cardiology and (2023) European Society of Hypertension criteria for resistant HTN and were included in our study. We matched these patients to 128 hospitalized patients with controlled HTN.

The Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy

This is a prospective, multicenter, randomized controlled study designed to evaluate the effect of renal denervation (RDN) ablation duration on blood pressure reduction in patients with hypertension. A total of 220 eligible patients with hypertension will be randomly assigned in a 1:1 ratio to one of two treatment groups. All participants will undergo renal denervation using a radiofrequency ablation system and a single-use multielectrode renal denervation catheter. In Group 1, each ablation site in the main renal arteries and their branches will be treated for 1 minute. In Group 2, each ablation site in the main renal arteries will be treated for 2 minutes, while each site in the renal artery branches will be treated for 1 minute. The study aims to determine whether a longer ablation duration in the main renal arteries provides greater blood pressure reduction and clinical benefit. Participants will be followed up at 1, 3, 6, and 12 months after the procedure to assess blood pressure and clinical outcomes.

Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension

According to WHO estimates, worldwide, 1.28 billion adults between the age of 30-79 years have hypertension. Furthermore, only 1 in 5 people with hypertension have it under control. In approximately 15% of the patients treated for hypertension, optimum blood pressure levels are not achieved even after the addition of 3-4 conventional anti-hypertensive drugs. These patients are diagnosed as resistant hypertensives. Resistant hypertension is associated with an increased risk of cardiovascular death, myocardial infarction, and stroke. Hypertension is a chronic condition where arterial pressures are persistently elevated, leading to an increase in the pulsatile load on the arteries. This can result in structural and functional alterations in the arterial wall leading to an increase in 'arterial stiffness'. Arterial stiffness is dependent on the mechanical load (blood pressure) and the material properties of the vessel wall. There is a vicious loop between hypertension and arterial stiffness, where hypertension may lead to alteration in the vascular structure and cause degradation of the elastic components of the vessel wall, and an increase in arterial stiffness can lead to higher blood pressure. An increase in arterial stiffness is associated with higher cardiovascular disease (CVD) risk, and patients with resistant hypertension are at a significantly higher risk of developing CVD. Measurement of carotid-femoral pulse wave velocity (PWV) is considered the gold standard for assessing arterial stiffness and has been recommended as a method to evaluate arterial stiffness as a part of routine care in patients with hypertension. The European Society of Hypertension (ESH) and the working group of the European Society of Cardiology (ESC) recommend its use for the evaluation of cardiovascular risk.

The RESPLASH Study

To assess the safety and effectiveness of renal artery denervation with subsequent splanchnic nerves denervation via catheter-based radiofrequency ablation in improving blood pressure and glycemic control in patients with resistant hypertension and type 2 diabetes.

A Phase II Study of VB19055 in Uncontrolled or Resistant Hypertension

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of VB19055 for 12 weeks in 240 adults with uncontrolled hypertension (including resistant hypertension).

Allopurinol Improves Heart Function in African Americans With Resistant Hypertension

African American adults in the United States have the highest prevalence rate of high blood pressure (hypertension) and heart failure in the world. African Americans with treatment resistant hypertension have higher levels of the enzyme - xanthine oxidase compared to Caucasians. This trial will test if administration of the xanthine oxidase inhibitor - Allopurinol (commonly used in the treatment of gout), given over a period of 8 weeks, will improve heart function, exercise ability and quality of life in African American Veterans with resistant hypertension.

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

This is a Phase II, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, and effect of low, middle and high dose of SAL0120 versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 256 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension

HQ-HTN-K01-02 is a prospective, multicenter, single arm, open label, first-in-human study to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications

Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

A Study Evaluating Aprocitentan Tablets(SYH9108) for the Treatment of Resistant Hypertension

Aprocitentan tablets are currently the only endothelin dual receptor antagonist approved internationally for the treatment of resistant hypertension.This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of aprocitentan tablets(SYH9108) in patients with treatment-resistant hypertension (rHTN)

An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)

This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.

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.

Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients

Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.

Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Systemic arterial hypertension is a serious health problem worldwide. In some cases, it can phenotypically present as resistant arterial hypertension, which consists of blood pressure levels outside the treatment goals in patients using three or more classes of antihypertensive drugs, one of which is preferably a thiazide diuretic. Resistant hypertension contributes to a 47% higher risk of developing cardiovascular events when compared to patients with non-resistant hypertension. It is known that the microcirculation plays a relevant role in the pathophysiology of arterial hypertension. Furthermore, it is known that the cutaneous microvascular network is an adequate model and that it reflects the systemic microcirculation. In this sense, the present research proposes the study of cutaneous capillary density - through high resolution intravital microscopy - and of the endothelium-dependent and independent microvascular vasodilator response - by the speckle laser flowmetry method coupled to a pharmacological system of micro- iontophoresis - in patients diagnosed with resistant hypertension, with the aim of identifying changes in comparison with patients with non-resistant hypertension and normotensive individuals. Additionally, the evaluation of the association between systemic microvascular function and the presence of target organ lesions in this population may indicate that this is a new non-invasive way of stratifying cardiovascular risk in these individuals.

Endothelin-1 Receptor Blockade in Resistant Hypertension

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.

Effect of Electrical Stimulation and Exercise on Blood Flow in Patients With Resistant High Blood Pressure

The goal of this clinical trial is to learn if the combination between transcutaneous electrical nerve stimulation (TENS) and isometric exercise (IE) can improve blood pressure in men and women between 50 to 60 years old suffered from resistant hypertension which is a type of hypertension where blood pressure remains above your target goal despite the use of three or more different classes of antihypertensive medications at their maximum tolerated doses. The main question to answer is: Is there a significant effect on the combined use of TENS and IE on peripheral hemodynamic parameters in patients with resistant hypertension? Total sample will be 50 patients from both sexes I will compare between two groups: Experimental group (15 men, 10 women) will take: medication plus IE and TENS Control group (15 men, 10 women) will take: medication plus Conventional Physical Therapy Program

Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension

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.