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Hypertension clinical trials

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NCT ID: NCT04811092 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

HYPERION
Start date: March 18, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

NCT ID: NCT04808596 Recruiting - Clinical trials for Pulmonary Hypertension

Pulmonary Hypertension Biorepository and Registry

PHBR
Start date: August 10, 2020
Phase:
Study type: Observational [Patient Registry]

Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

NCT ID: NCT04807803 Recruiting - Cirrhosis Clinical Trials

Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

Evencipor
Start date: March 26, 2021
Phase: N/A
Study type: Interventional

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

NCT ID: NCT04800081 Recruiting - Hypertension Clinical Trials

Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension

Start date: July 9, 2020
Phase: N/A
Study type: Interventional

To explore the efficacy of Sacubitril/Valsartan in the treatment of perimenopausal hypertensive patients, as well as the difference between the antihypertensive efficacy and valsartan, the therapeutic effect of its exposure to different factors and the protection of target organs.To provide reference for the clinical treatment of perimenopausal hypertension patients with shakubactrivalsartan. 1. To evaluate the effects of Sacubitril/Valsartan on urinary microalbumin and pulse wave velocity in perimenopausal hypertension patients. 2. To evaluate the clinical application of Sacubitril/Valsartan in the treatment of perimenopausal hypertension, so as to improve the blood pressure management ability and control rate of patients with such hypertension.

NCT ID: NCT04797403 Recruiting - Hypertension Clinical Trials

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline

IMPACTS-MIND
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

The study will test a multifaceted strategy for implementing an intensive blood pressure intervention protocol targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in primary care. The proposed study will generate urgently needed data on effective, adoptable, and equitable intervention strategies to reduce blood pressure-related cognitive decline in low- income and minority populations. If proven effective, the implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

SOTERIA
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04790942 Recruiting - Hypertension Clinical Trials

Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension

Start date: October 22, 2020
Phase: Phase 4
Study type: Interventional

Hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. It is the leading risk factor of cardiovascular disease. Berberine (BBR) hydrochloride is an isoquinoline alkaloid (chemical formula: C20H18NO4) extracted from traditional Chinese herb Coptis chinensis. It has been widely used to treat diarrhea and enteritis for hundreds of years in China. BBR has extremely high clinical application value. It is an over-the-counter drug with low price, good safety and few adverse reactions in China. We found that Berberine (BBR) hydrochloride tablets have a hypotensive effect in clinical practice. However, there are few clinical studies on the treatment of hypertensive patients with BBR tablets. In addition, the clinical dosage of BBR tablets is not uniform, and its molecular mechanism is still unclear. In order to further evaluate the clinical efficacy of BBR in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population. After signed the informed consent, the subjects are assigned to the lifestyle intervention group (CON) and berberine hydrochloride group (BBR). The berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . We will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.

NCT ID: NCT04780932 Recruiting - Chronic Disease Clinical Trials

Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension

IMPACT-CTEPH
Start date: June 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic thromboembolic pulmonary hypertension (CTEPH) is characterised by an obstruction of proximal or more distal pulmonary arteries by residual organized thrombi, combined with a variable microscopic pulmonary vasculopathy (microvasculopathy). Besides lifelong anticoagulation, surgical pulmonary endarterectomy is the treatment of choice in subjects with proximal CTEPH affecting large pulmonary arteries. However, around half of CTEPH subjects are not operated, mainly because of distal lesions inaccessible to surgery. International data have reported survival rates of 88, 79, and 70% at 1, 2, and 3 years, respectively, in subjects with inoperable CTEPH, underscoring the need for better treatment strategies. In those subjects, current guidelines recommend medical therapy with or without balloon pulmonary angioplasty (BPA). Currently, only one drug (riociguat), targeting the NO pathway, is approved and reimbursed in Europe. Thus, riociguat monotherapy is considered as the standard-of-care treatment for subjects newly diagnosed with inoperable CTEPH. Recently, macitentan, targeting the endothelin-1 pathway, showed to be also effective in subjects with inoperable CTEPH. However, macitentan is currently not approved for CTEPH in Europe. BPA has been also reported to improve hemodynamics, symptoms and exercise capacity. However, complications, including mainly vascular injury, may occur during this procedure and it has been shown that the risk of BPA-related complications was strongly related to the level of pre-BPA mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR). Medical therapy and BPA have in fact complementary effects since they target different lesions. Indeed, BPA targets fibrotic organized thrombi in the segmental arteries down to small pulmonary arteries of 2-5 mm in diameter. Medical therapy, for its part, targets microvasculopathy, similar to that observed in pulmonary arterial hypertension (PAH), in vessels less than 0.5 mm in diameter. Therefore, it is strongly believed that the use of medical therapy prior to BPA may reduce the risk of BPA-related complications by improving pulmonary hemodynamics and may improve global efficacy. In PAH, initial dual oral combination therapy with drugs targeting the NO and endothelin pathways is considered as a standard of care, more efficacious than monotherapy and safe. In contrast, there are no data from controlled trials regarding the efficacy and safety of initial combination therapy regimens versus standard-of-care monotherapy in treatment-naïve subjects with inoperable CTEPH. The investigators hypothesize that initial dual oral combination therapy may be superior to standard-of-care riociguat monotherapy for improving pulmonary hemodynamics prior to BPA and for reducing the risk of BPA-related complications.

NCT ID: NCT04778046 Recruiting - COPD Clinical Trials

Pulmonary Hypertension SOLAR

PH SOLAR
Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.