A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
NCT05321368 · Hypertension, High Blood Pressure, Diabetes
RecruitingThe LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
PhaseNA
TypeInterventional
Age18 Years
WhereWashington D.C., District of Columbia, United States + 2 more
SponsorJohns Hopkins University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Engagement Alliance Against Disparities
NCT06607341 · Diabetes, Pre-diabetes, Hypertension
RecruitingThe Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard University, Johns Hopkins University, Morgan State University, and the University of Maryland, Baltimore-has established a regional structure for bi-directional community involvement to engender trust and foster communication. Each site builds on thriving community partnerships, which have been instrumental in enhancing trust, community capacity, and readiness to reduce health disparities.
PhaseNA
TypeInterventional
Age18 Years
WhereWashington D.C., District of Columbia, United States + 1 more
SponsorJohns Hopkins University
▾Tap for detailsClick for full details — eligibility, all locations, contacts BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT06059638 · Hypertension, Hypertension, Systolic, Hypertension, Essential
RecruitingA prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
PhaseNA
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 98 more
SponsorOrchestra BioMed, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
NCT05587712 · Pulmonary Arterial Hypertension
RecruitingThe primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.
PhasePhase 2
TypeInterventional
Age1 Year – 17 Years
WhereLos Angeles, California, United States + 34 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
NCT06742723 · Chronic Kidney Disease and Hypertension
RecruitingInternational, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
PhasePhase 3
TypeInterventional
Age18 Years
WhereFairhope, Alabama, United States + 755 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Non-invasive Central Venous Pressure Estimation in Pediatric Patients
NCT06885073 · Central Venous Pressure
RecruitingCentral Venous Pressure (CVP) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. The pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device (CPMX2) in children equipped with an invasive catheter for CVP monitoring as part of standard of care.
PhaseNA
TypeInterventional
Age21 Years
WhereWashington D.C., District of Columbia, United States
SponsorCompremium AG
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
NCT07175038 · Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension, Interstitial Lung Disease
RecruitingThis study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 15 more
SponsorAllRock Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
NCT04669548 · Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury
RecruitingThe Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
Phase—
TypeObservational
Age18 Years
WhereLos Angeles, California, United States + 8 more
SponsorPotrero Medical
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
NCT06526195 · Heart Failure, Heart Diseases, Cardiovascular Diseases
RecruitingThe purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
PhaseNA
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 62 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts Natural History of Sickle Cell Disease
NCT00081523 · Pain Crisis
RecruitingThis study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.
Phase—
TypeObservational
Age2 Years – 90 Years
WhereWashington D.C., District of Columbia, United States + 2 more
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT06388421 · Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease
RecruitingThis is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 60 more
SponsorUnited Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts