REVIEWIncidence and Impact of Hyperkalaemia on RAASi Therapy in HFrEF and Post-MI Patients
This observational study aims to determine the frequency and impact of high potassium levels (hyperkalaemia) on the therapy with RAAS inhibitors (RAASi) in patients with heart failure with reduced ejection fraction (HFrEF) and those who have had a heart attack (post-MI).
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+5
+ Heart Diseases
+ Hyperkalemia
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 12, 2021
Actual date on which the first participant was enrolled.This study focuses on a condition called hyperkalaemia, which is an elevated level of potassium in the blood. It's particularly interested in patients who have recently been diagnosed with heart failure with reduced ejection fraction (HFrEF), including those who have recently had a heart attack. The study aims to understand how often hyperkalaemia occurs in these patients after they start taking renin-angiotensin-aldosterone system inhibitors (RAASi), a type of medication commonly used to manage heart conditions. It also wants to see how hyperkalaemia affects the prescription of these drugs and how healthcare professionals make changes to these prescriptions when a patient has high potassium levels. In this observational study, researchers will look at how often patients with HFrEF need to reduce or stop their RAASi dosage due to hyperkalaemia. They will also measure the frequency of hyperkalaemia in patients newly started on RAASi. Additionally, the study will assess the proportion of patients who have high potassium levels while in the hospital or emergency department and require changes to their RAASi treatment. The study's outcomes will help understand the impact of hyperkalaemia on the management of heart conditions with RAASi.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.651 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
For patients with heart failure Inclusion criteria 1. Patients with newly diagnosed HFrEF (within 4 weeks of diagnosis, including those with post MI LVSD, identified as outpatients or during hospital admission, typically for decompensated heart failure or post myocardial infarction) who are initiated on RAASi or have a clinical indication for uptitration of current RAASi (in patients already receiving RAASi for other indications). 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. Patients receiving dialysis. For patients with hyperkalaemia Inclusion criteria 1. Patients in ED or inpatients who already receive RAASi and who have at least 1 blood test with a potassium level of ≥5.5 mmol/l. 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. Patients receiving dialysis. For healthcare professionals: Inclusion criteria 1. Doctors, pharmacists, non-medical prescribers working at primary and secondary care. 2. Able to provide informed consent. 3. Age 18 and above. Exclusion criteria: 1. None As this is an observational study, patients in other research studies or receiving any specific treatments for hyperkalaemia (other than chronic dialysis) will not be excluded. After consent, patients will also be permitted to participate in other research studies should they so wish. Patients with covid-19 can also be included.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Portsmouth Hospitals University NHS Trust
Portsmouth, United KingdomOpen Portsmouth Hospitals University NHS Trust in Google Maps