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NCT ID: NCT06335433 Recruiting - Hypertension Clinical Trials

Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, & Phillips, 2021, Toohey et al, 2018). Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure. Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses.

NCT ID: NCT06335173 Recruiting - Alzheimer Disease Clinical Trials

A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

ALTITUDE-AD
Start date: February 29, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

NCT ID: NCT06334822 Not yet recruiting - Heart Failure Clinical Trials

Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK.

HF-TRACK
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization. Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly. The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy. This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges.

NCT ID: NCT06334718 Recruiting - Clinical trials for Cardiac Arrest, Out-Of-Hospital

Drone Delivered Defibrillators (The 3D Project).

Start date: March 29, 2024
Phase:
Study type: Observational

The goal of this observational study is to explore the optimisation and integration of a drone-delivered Automated External Defibrillator (AED) system into the pre-hospital response to out-of-hospital cardiac arrest. The study is being conducted by the University of Warwick and Welsh Ambulance Service National Health Service Trust (both in the UK) There are two separate packages of work. In work package 1 the investigators will interview people who have been involved in emergency (999) calls for cardiac arrest, asking them about their experiences with the call-handler and how they feel they might have responded if they had received an AED that had been delivered by a flying drone. In work package 2 the investigators will conduct simulated cardiac arrests. The participants in the study will make an emergency (999) call to a trained call-handler and, once the cardiac arrest is identified during the call, a drone will be activated from a distant location and fly up to 2km to the test site and deliver an AED. The investigators will record how long it takes to retrieve and attach the AED, and ask the participants for their views about the interaction with the call-handler, AED and drone.

NCT ID: NCT06334575 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

3TR-ICS-COPD
Start date: July 2024
Phase: Phase 4
Study type: Interventional

The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or > 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome

NCT ID: NCT06334250 Not yet recruiting - Atrial Fibrillation Clinical Trials

Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial

PLANET-AF
Start date: April 2024
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation.

NCT ID: NCT06334224 Recruiting - Muscle Weakness Clinical Trials

Acute Physiological Responses to Twice Daily Blood Flow Restriction Training

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown. Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere.

NCT ID: NCT06333483 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE)

CARLYSE
Start date: February 2, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.

NCT ID: NCT06333223 Recruiting - Menopause Clinical Trials

Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis

SYMPTOGUT
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics. To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far.

NCT ID: NCT06333184 Recruiting - Clinical trials for Metabolic Disturbance

Smoothies and Blood Sugars

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.