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Hypertension clinical trials

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NCT ID: NCT05236348 Recruiting - Hypertension Clinical Trials

Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation

Start date: January 11, 2022
Phase: N/A
Study type: Interventional

This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.

NCT ID: NCT05224531 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Effect of CS1 in Subjects With Pulmonary Arterial Hypertension

Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, parallel group study to evaluate the safety, tolerability, PK, and exploratory efficacy of 3 doses of CS1 in the treatment of PAH using the CardioMEMS HF System to obtain repeated measurements of PAP and other hemodynamic parameters. Elegible subjects will have a RHC to implant the CardioMEMS pulmonary artery (PA) Sensor followed by a Baseline Period for the subject to become familiar with the system, its measurements, how to send the data, and establish Baseline PA pressure. Alternately, the subject may already have the CardioMEMS HF System and is willing to have the system recalibrated in conjunction with RHC. Thereafter, the subject will be randomly assigned to 1 of 3 total daily doses of CS1 1:1:1; there will be 10 subjects assigned to each dose level. Subjects will receive study drug treatment for 12 weeks. During the study, mPAP and other hemodynamic parameters from CardioMEMS PA Sensor will be measured and data captured once daily in the morning before the subject gets out of bed. The data will be transferred electronically to a repository. The analysis will look at the area under the curve (AUC) of mPAP and the doses will be compared to each other regarding change from Baseline. In addition to the CardioMEMS HF System measurements, the subjects will be followed for mortality and morbidity, important biomarkers as well as subjective, functional, and structural parameters of importance for PAH, for the duration of the study. Subjects will be enrolled for up to 22 weeks: a Screening Period of up to 2 weeks prior to the start of the Baseline Period, a Baseline Period of up to 6 weeks prior to Randomization, a Treatment Period of 12 weeks, and a Follow-up Period of 2 weeks. The primary objective of the study is to obtain safety and tolerability data.

NCT ID: NCT05223101 Recruiting - Hypertension Clinical Trials

A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers

Start date: January 19, 2022
Phase: Phase 1
Study type: Interventional

To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg in healthy adult volunteers

NCT ID: NCT05222191 Recruiting - Renal Insufficiency Clinical Trials

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

SPICE PILOT
Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

Highly prevalent among patients with chronic kidney disease (CKD) and poorly controlled blood pressure (BP), is a modifiable risk factor to abrogate both kidney failure progression and cardiovascular (CV) disease. Spironolactone (SPL), a mineralocorticoid receptor antagonist, is widely used to treat resistant hypertension, however one of the most common side effects is an increase of serum potassium (K). This side effect occurs frequently in those who suffer from CKD. Alternatively, chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K. In this pilot study, our goal is to assess whether the combination of SPL and CTD can improve BP control, while also reducing the risk of hyperkalemia over a period of 12 weeks. We hypothesize that among patients with CKD and poorly controlled hypertension, compared to SPL and placebo, treatment over 12 weeks with CTD will counter the hyperkalemia effect of SPL, and therefore the combination of SPL with CTD will result in a lower BP. This pilot study will be performed at Richard L. Roudebush VA in Indianapolis, Indiana.

NCT ID: NCT05220332 Recruiting - Hypertension Clinical Trials

Church-based Intervention to Improve Blood Pressure in African Americans

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.

NCT ID: NCT05207683 Recruiting - Clinical trials for Patients With Pulmonary Hypertension

Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology

Start date: October 1, 2021
Phase:
Study type: Observational

Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension

NCT ID: NCT05203510 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension

ARTISAN
Start date: August 10, 2022
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).

NCT ID: NCT05198674 Recruiting - Hypertension Clinical Trials

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

NCT ID: NCT05198206 Recruiting - Clinical trials for Pulmonary Hypertension

Pregnant Women With Pulmonary Hypertension in China

Start date: November 1, 2021
Phase:
Study type: Observational

Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with pulmonary hypertension in China. Eligible samples were screened from January, 2012 to December, 2021. Maternal clinical characteristics and in-and-out hospital outcomes were collected and compared in women with and without pulmonary hypertension. The main aims of this study are as follows: 1. To investigate the perinatal diagnosis and treatment of pregnant women with pulmonary hypertension in China over the past 10 years and the maternal and infant outcomes. 2. To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants. 3. To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy. 4. To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.

NCT ID: NCT05187013 Recruiting - Hypertension Clinical Trials

Uncontrolled Hypertension Among the Homeless

Start date: September 12, 2022
Phase: Phase 3
Study type: Interventional

This study is designed to assess the effect of implementing a mobile health (mHealth) strategy using text messaging for hypertension (HTN) management among hypertensive homeless persons with uncontrolled blood pressure age 21 or older in shelter-clinics in New York City (NYC). The study uses a randomized clinical trial design (homeless, n=120) and semi-structured interviews (homeless, n=30; providers, n=20). The control group will receive text messages for usual standard care/healthy lifestyle during a 6-month follow-up period. The intervention group will receive text messages geared towards both standard care/healthy lifestyle and blood pressure control. At the end of study period, the investigators will assess changes in blood pressure (BP) measurements, adherence to clinic visits, and adherence to medication, and the investigators will compare them between the two groups. Qualitative interviews with both patients and providers who provide services to the homeless in shelter settings will develop a better understand barriers and opportunities regarding BP control. The investigators hypothesize that those individuals randomized to the intervention will experience a reduction in blood pressure (8mmHg systolic BP or diastolic BP) and will exhibit better adherence to blood pressure medications and appointments compared to the control group.