Dr. Mary Mooney

This innovative study aims to identify the unmet needs of women in menopause and their health research priorities, and potential solutions to optimise menopausal health. The transformative element is focused on co-creating with women and healthcare professionals, a blueprint for personalised health and management of menopausal symptoms. This blueprint will inform national and international policy for directing future menopausal services and research priorities.

European Commission (2021) Purpose: VALIDATION OF ARTIFICIAL MODELS FOR PREDICTING DECOMPENSATIONS AND IMPROVING QUALITY OF LIFE IN HEART FAILURE Topic HORIZON-HLTH-2021-DISEASE-04-04- Clinical validation of AI solutions for treatment and care. VALHALLA's (acronym for the group of contributors) main objective is to refine a proof-of-concept (AI) model previously devised in another patient cohort for prediction of decompensation in Heart Failure (HF) patients in telemonitoring scenarios. The study aims to optimise data capture methods (including evaluation of novel wearable devices for HF telemonitoring) which will be evaluated at different sites and countries. The study will use large-scale clinical validation of the model for HF management, comparing the standard of telecare with the AI-enabled predictive approach in terms of relevant clinical outcomes, to provide clinical evidence for its widespread adoption; to evaluate in terms of healthcare integration, acceptance and cost-effectiveness the feasibility of its incorporation in different settings across different European countries and Colombia; and to prepare for qualification according to regulatory requirements such as the new EU Medical Device Regulation. The outcomes The primary outcome will be the percentage of days lost due to unplanned cardiovascular hospital admissions or death from any cause, comparing remote patient management plus usual care to usual care alone during the individual patient follow-up time. The main secondary outcomes will be all-cause mortality and cardiovascular mortality during the individual patient's follow-up time plus 28 days after the last study visit, to a maximum of 197 days; percentage of days lost due to unplanned cardiovascular hospital admissions, and percentage of days lost due to unplanned heart failure hospital admissions; change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) global score. The PROMs and PREMs, and QoL questionaries will also be measure.

Heart failure (HF) is a chronic condition that can lead to a deterioration in functional capacity and quality of life. The pathogenesis of heart failure is varied, and the course of the syndrome varies. In keeping with best practice, patients with HF are routinely asked to record their daily weights. While patients' adherence to daily weight recording is generally good, owing to a reduction in numeracy and cognition skills associated with heart failure, many patients struggle with cumulative weight calculations and its association with worsening heart failure. If patients could identify that increasing weight is a precursor to worsening heart efficiency, they would potentially seek help at an earlier stage than currently happens. Prompt identification of weight gain before symptoms manifest, coupled with rapid intervention are key to optimising successful patient outcomes. COVID19 has led to a reduction in face to face clinics so there is now an increased onus on the patient to identify a significant increase in their weight. We devised the 'Fluid Heart Tracker App' to support patients with this aspect of their care. This App is compatible with all smart phone devices. It allows patients enter daily weights and it automatically calculates weight over a rolling seven-day period. If an increase in weight is detected, the patient receives an alert advising them to contact their doctor or heart failure nurse. If no significant increase is detected, a green alert message informs the patient that weight is stable. The App has been simplified to maximise user-friendliness and has been approved for use by the Irish Heart Foundation. Using a quasi-experimental, pre-test post-test design, we will evaluate the use, impact, effect and perceived value of the App on patients with heart failure and heart failure nurses. We will gather baseline data and post App-use data for comparison of measurable outcomes, such as quality of life, help-seeking behaviours, use of the App, effect of the App in expediting help, readmission rates, length of stay when hospitalised, biochemical markers and resource use. Sixteen Irish hospitals have agreed in principle to participate, with 16 specialist heart failure nurses acting as study gatekeepers and clinical site leads. The study will be conducted over 36 months, with 50 patients recruited from each site.

The primary objective of the study is to test the effectiveness of a study-specific blood pressure (B/P) monitor, and a study-specific weighing scales, together with the fluid heart tracker app (triple pack) in patients with heart failure. The secondary objective is to qualitatively assess participants and healthcare providers" perceived usefulness and clinical acceptability of the triple pack.

In 2017 the primary care reimbursement service of Ireland approved the use of LCZ696 (which later became known as Entresto) to be used following strict guidelines for use in selected patients with HFrEF. For patients with HFrEF who do not meet the criteria for use of Entresto and who have a systolic BP>100mmHg and no history of angioedema a ACE inhibitor is recommended or ARB if intolerant to ACE inhibitor (Grade 1A recommendation see reference more details). This was following PARADIGM-HF trial (McMurray et all, 2014). The study found LCZ696 was superior to enalapril in reducing the risk of death and of hospitalisation for heart failure. The study found that by reducing the inhibition of both the angiotensin II inhibitor receptor and neprilysin with Entresto, it therefore reduced the risk of death from cardiovascular causes or hospitalisation for heart failure the ACE inhibitor. The LCZ696 was also superior to enalapril in reducing symptoms and physical limitations of heart failure. These robust findings provided strong evidence that combined inhibition of the angiotensin receptor and nepilysin is superior to inhibition of the renin-angiotensin system alone inpatient with chronic heart failure. This study will quantify the effects of Entresto in HF patients using secondary data analysis.