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Hypertension clinical trials

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NCT ID: NCT05545059 Recruiting - Clinical trials for Resistant Hypertension

Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension

Start date: September 24, 2022
Phase: Phase 3
Study type: Interventional

Resistant hypertension (RH) accounted for a considerable proportion of patients with hypertension. It has been revealed to impose certain adverse effects on the prognosis of patients with cardiovascular diseases. The antihypertensive effect of sacubitril/valsartan being fully confirmed in previous studies, there were no related randomized controlled trials (RCT) about this potency among Chinese patients with RH. The investigators designed this study to evaluated effects and safety of sacubitril/valsartan versus valsartan on Chinese patients with RH.

NCT ID: NCT05543720 Recruiting - Hypertension Clinical Trials

Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more. Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits. In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.

NCT ID: NCT05530512 Recruiting - Clinical trials for Mild to Moderate Hypertension

Acupuncture Therapy and Hypertension

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

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on hypertensive medications. The course last for 8 weeks and the frequency is once a week.

NCT ID: NCT05528419 Recruiting - Hypertension Clinical Trials

Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation

Start date: February 6, 2023
Phase: Phase 4
Study type: Interventional

Study name: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation. Medicine: sacubitril/valsartan (100mg) and valsartan (80mg). Rationale: The latest guidelines represent an intensified management approach to reduce or prevent morbidity associated with atrial fibrillation. They provide stronger and more specific recommendations for catheter ablation (CA) use. However, not all patients maintain sinus rhythm after CA and both early and late relapses of AF can occur in many patients. Objective: To evaluate the efficacy and safety of sacubitril/valsartan in preventing atrial fibrillation recurrences after ablation in elderly hypertensive patients with atrial fibrillation. Study design: This is a 12-month prospective, randomized, active-controlled, open-label, multi-center study, with two treatment groups: sacubitril/valsartan (100mg tablet) and valsartan (80mg tablet). Study population: Men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated and treated atrial fibrillation patients with clinic systolic/diastolic blood pressure ≥130/80 mmHg, who are going to receive catheter ablation procedure. Patients should have abilities to understand the study requirements and provide informed consent. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (100mg tablet) or valsartan (80mg tablet). Follow-up: After meeting the inclusion criteria, there will be 1-week screening period. Clinic blood pressure, ambulatory blood pressure, echocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into sacubitril/valsartan group and valsartan group. The treatment will be observed for 12 months. There will be 4 visiting points in the treatment period, which will be the 1st month, 3rd month, 6th month and 12th month. Sample size: A total of 300 patients should be enrolled in total. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital, recruitment will start. Patients enrollment and follow-up are expected to be performed from October 2022 to December 2024.

NCT ID: NCT05528068 Recruiting - Hypertension Clinical Trials

Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure

Start date: July 27, 2022
Phase: N/A
Study type: Interventional

Hypertension is a major risk factor for cardiovascular disease and cardiovascular events. Healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. Increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. The aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.

NCT ID: NCT05526703 Recruiting - Clinical trials for Essential Hypertension

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Start date: September 28, 2022
Phase: Phase 3
Study type: Interventional

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.

NCT ID: NCT05526300 Recruiting - Clinical trials for To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

Intelligent Hypertension Intervention Study

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)

NCT ID: NCT05526170 Recruiting - Atrial Fibrillation Clinical Trials

Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

TriggersAF
Start date: August 1, 2021
Phase:
Study type: Observational

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

NCT ID: NCT05524987 Recruiting - Hypertension Clinical Trials

Addressing HyperteNsion and Diabetes Through Community-Engaged Systems in Puno, Peru (ANDES Study)

ANDES
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Hypertension (HTN) has become the largest driver of morbidity and mortality (M&M) worldwide, affecting nearly 1 billion persons, the vast majority living in low- and middle-income countries (LMICs). While clinical research has identified highly-efficacious and inexpensive options to control HTN, rates of awareness, treatment and control of HTN are abysmally low. Implementation strategies that can effectively reach and engage patient populations while feasible within the constraints of frail health systems are urgently needed. In Peru, less than 10% of those with HTN are optimally controlled and thus avoidable M&M continues to increase at unacceptable levels. In the proposed ANDES strategy, ANDES research team will study a vulnerable, impoverished indigenous Andean population that has a high prevalence of HTN (18.5%) and Type 2 Diabetes (T2D) (7.4%); living at high altitude. The study has two phases: UG3/UH3. During the formative UG3 phase (ended 12/31/22) we completed 3 aims, including: a) adapting community-based service delivery models for detection/control of HTN/T2D using stakeholder-engaged approaches; and b) assessed short-term implementation and service outcomes of pilot Health Fairs to detect HTN/T2D and a CHW-led model for engagement and treatment of HTN/T2D in two communities. A number of stakeholder in-depth interviews revealed significant limitations to HTN control. Discrete Choice Experiments (DCEs) surveys helped understand attributes for a community health worker (CHW)-led HTN care program that patients would value. Human-Centered Design was used to refine CHWs manual prototype, frequency and content of training sessions on patients, training CHW, supervision and integration into the healthcare system; facility-based health worker training content and approaches; identified opportunities for CHWs to improve health care system by helping to promote hypertension diagnosis, treatment and control. All these activities were used to refine the protocol that was tested in the pilot study where 1,079 subjects underwent blood pressure monitoring under a Standard Operating Procedure using electronic tablets to construct a REDCap database. The UH3 phase will test the adapted ANDES strategy. ANDES is a two-arm, individually randomized superiority trial with parallel assignment. The overall objective of ANDES is to evaluate the effectiveness of a home-based Health Agent-led intervention in reducing blood pressure and improving diabetes control in patients from under-resourced communities in Puno, Peru. Potential ANDES study participants will be identified, screened, and recruited via 2 different mechanisms: 1) community health fairs and 2) healthcare facility-based enrollment. Health fair planning, will be conducted in collaboration with DIRESA & EsSalud and local healthcare facility leaders. All health fair attendees will be screened for blood pressure measurements. ANDES research study staff will do screening at tents in the health facilities after doctors refer patients (or for any patients to visit who want) to inquire about their willingness for an in-person screening visit at their home. Recruitment will be rolling over 24 months during which 1068 participants in total (534 participants per arm) will be enrolled. To detect a difference in systolic blood pressure of 2.5 mmHg between intervention and control arms with 95% confidence, 90% power and a standard deviation of 12 mmHg, ANDES research team would need 485 participants per arm. Assuming a conservative lost-to-follow-up of 10% at 12 months, ANDES research team would need to randomize 1068 participants in total (534 participants per arm). The primary outcome is to determine if the ANDES intervention impacts SBP in comparison to the usual care arm 12 months after randomization. ANDES participants will initiate one of two care pathways according to the randomization assignment. Participants in the usual care group will be referred to their local healthcare facility for evaluation and/or to receive medical therapy per typical standard of care and at the discretion of the treating physician for the entirety of the ANDES study. Participants in the ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months. Implementation package delivery will end after month 12, at which time intervention participants will be advised to obtain standard care from their local healthcare facility. Study outcome measures will be obtained in both the usual care and ANDES intervention group at months 12 and 18 post-randomization. All participants will receive visits at baseline, 12 and 18 months for study outcome assessments. Intervention participants will additionally receive a total of 12 visits by health agents as part of the intervention package, for a total of 18 visits for those assigned to the intervention group.

NCT ID: NCT05523557 Recruiting - Clinical trials for Pulmonary Hypertension

Urban-training Intervention in Pulmonary Hypertension (UTHAP)

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

Pulmonary rehabilitation is effective in the treatment of pulmonary hypertension (PH). However, the beneficial effects of such intervention have been seen to disappear over time in other chronic diseases. The objective of the project is to evaluate the efficacy of an urban exercise program after a rehabilitation program and to identify possible determinants of sustainability of the effect, both in patients and in a murine experimental model. Methodology: 1) Study in humans: randomized study (urban training) in 80 patients with PH. The main variable is the improvement in physical activity measured by accelerometry at 12 months. Improvements in bioimpedance and aerobic capacity will be analysed as secondary variables, as well as possible determinants of vascular function that guarantee the sustainability of the effect (pulse wave velocity, endothelial function, metabolic profile and other plasma biomarkers), and all of them will be correlated with the evolution of the disease (admission due to clinical deterioration). 2) Studies in a murine experimental model: Mice with pulmonary hypertension induced by the administration of SU5416 (sugen) and exposure to hypoxia for 3 weeks will be studied after a three-week rehabilitation program. Half of them will exercise 1-2 days a week for 4 more weeks. At the end of the program, the right ventricular pressure will be measured and subsequently the animals will be sacrificed. Morphometric studies will be performed on lung, cardiac and muscular tissue. Vascular endothelial function and autophagy will be also measured. The differences in these variables between the different experimental groups will be analysed.