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NCT ID: NCT05007847 Recruiting - Atrial Fibrillation Clinical Trials

Improving AF Detection in Cryptogenic Stroke

CSAF-AW
Start date: February 4, 2022
Phase: N/A
Study type: Interventional

No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy. A randomised controlled study in 2014 showed that whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Prolonged monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields. The Apple Watch (AW) is a wristwatch able to monitor a wearer's heart rate and rhythm regularity and facilitates real- time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.

NCT ID: NCT05006716 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Start date: September 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

NCT ID: NCT05006196 Recruiting - Breast Cancer Clinical Trials

Contrast-Free Magnetic Resonance Imaging for Breast Disease

IMOGEN
Start date: July 6, 2021
Phase:
Study type: Observational

Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.

NCT ID: NCT05005949 Recruiting - Clinical trials for Persistent Atrial Fibrillation

STOP Persistent AF PAS

Start date: August 19, 2021
Phase:
Study type: Observational

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

NCT ID: NCT05005689 Recruiting - Clinical trials for Orthodontic Appliance Complication

Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

FL4OWS
Start date: October 20, 2023
Phase: Phase 4
Study type: Interventional

The aim of this 2-armed, parallel, randomised, controlled trial is to assess the effect of different ways of applying fluoride to teeth on the formation of white spots (enamel demineralisation), during orthodontic treatment with fixed metal braces, in children and adolescents.

NCT ID: NCT05004363 Recruiting - Clinical trials for Chronic Kidney Diseases

Lokelma for RAAS Maximisation in CKD & Heart Failure.

LIFT
Start date: January 19, 2022
Phase: Phase 3
Study type: Interventional

Background: CKD in patients with heart failure (HF) is common and associated with poor prognosis. Despite evidence of benefit with Renin-Angiotensin-Aldosterone-System inhibitor (RAASi) agents, they are avoided due to fear of hyperkalaemia. New potassium binders, e.g. Sodium Zirconium Cyclosilicate (SZC), reduce incidence of hyperkalaemia in CKD-HF patients and hence may help RAASi maximisation, which has not been investigated in an RCT. Purpose: The proposed study will randomise HFrEF patients with stable CKD 3-5 and serum potassium 5-5.0 mmol/L, to receive SZC or placebo while RAASi therapy is maximised. The aim of the study is to examine if SZC is superior to placebo in achieving maximal doses of ACEi/ARB, e.g. Ramipril 10 mg, Candesartan 32 mg; and mineralocorticoid receptor antagonist, e.g. Epleronone 50 mg or Spironolactone 50 mg, avoiding hyperkalaemia. Methods: Eligible patients with eGFR<60 mL/min/1.73m2, heart failure (EF<40%) on none/submaximal dose of RAASi will be randomised to receive 10g TDS of investigational medicinal product (IMP), either SZC or placebo, for 48 hours and in 10 or 5g OD guided by laboratory serum potassium (K+). Every two weeks the RAASi dose will be increased and IMP adjusted according to a strict protocol and guided by laboratory potassium and creatinine. The primary endpoint of the study is achievement of maximal dose of RAASi in randomised patients avoiding hyperkalaemia, i.e. K+≤5.6 mmol/L. Patients will be allowed to continue with RAASi maximisation to K+<6.0mmol/L. Patients will be tested at baseline and follow-up visits for hyperkalaemia, AKI, symptomatic hypotension and QT prolongation on ECG. Results: The study results will show if SZC is superior to placebo for RAASi maximisation in CKD-HF patients while maintaining safe levels of serum potassium without any adverse impact on quality of life. The study will demonstrate if SZC allows higher RAASi dose and more dose escalations than placebo. It will also examine the impact of RAASi escalation on creatinine, proteinuria, and cardiac blood biomarkers. Conclusion: If positive, the results of this study will demonstrate that SZC enables RAASi up titration in CKD-HF patients, which potentially can help achieve optimal treatment and improve quality of life of the patient.

NCT ID: NCT05003986 Recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

EPPIK
Start date: August 12, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.

NCT ID: NCT05003817 Recruiting - Clinical trials for Coronary Artery Disease

Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

CHIP-BCIS3
Start date: August 6, 2021
Phase: Phase 3
Study type: Interventional

Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack. For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle. A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device. The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

NCT ID: NCT05002543 Recruiting - Clinical trials for Cardiac Valve Disease

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

MANTRA
Start date: June 29, 2021
Phase:
Study type: Observational [Patient Registry]

MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting. Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease. The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products. Currently, three sub-studies are planned: - MANTRA - Aortic Sub-Study - MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D) - MANTRA - Memo 4D Sub-Study

NCT ID: NCT05002127 Recruiting - Gastric Cancer Clinical Trials

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

Start date: January 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.