Non-invasive assessment of cardiac function to identify heart failure
Research type
Research Study
Full title
Sensitivity and specificity of non-invasive cardiac output assessment to identify heart failure
IRAS ID
211195
Contact name
Djordje Jakovljevic
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
1369, Clinical Research Facility
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
Background: Heart failure (HF) is a complex clinical syndrome presented with reduced ability of the heart to pump blood i.e. cardiac dysfunction. Early identification of HF is crucial because starting appropriate treatment quickly can slow down the disease progression and lead to better patient outcomes and more effective care. Primary care physicians have a key role in identifying HF, but due to reduced accuracy of diagnostic tests available to them, HF often remains misdiagnosed or underdiagnosed.
Aim: To assess accuracy of non-invasive measurement cardiac output to identify (diagnose) heart failure.
Methodology: The research will include recruitment of forty healthy volunteers (>50 years of age) and 80 patients suspected of having HF.
Healthy volunteers will be asked to attend the Clinical Research Facility at the Royal Victoria Infirmary on one occasion only with duration of approximately 1.5 hours. After reading patient information sheet and after having had time to make a decision and ask any questions to the member of research team, participants will be asked to sign the consent form saying that they would like to take part in this research study. They will be asked to complete a Medical History Questionnaire, undertake a short physical examination, anthropometric data (i.e. includes height and weight), and blood pressure will be measured and a resting electrocardiogram (ECG) recorded. Then they will be connected to heart and gas-exchange monitors to measure heart function and metabolism (i.e. amount of oxygen that body consume) wearing a face mask to collect expired gases. Measurements will be performed for 12 minutes i.e. 3-min supine, 3-min standing, and 6-min exercise step-test protocol. After a 30-min resting period measurements will be repeated in the same order i.e. supine, standing, and exercise step-test protocol.Patients referred by their GPs to attend the Heart Failure Diagnostic Clinic at the Royal Victoria Infirmary, as part of the standard care and practice in the Heart Failure Diagnostic Clinic, will perform the following investigations performed by specialised NHS staff members: Echocardiography (ultrasound for assessment of heart structure and function), electrocardiogram (ECG, electrical tracing of the heartbeat), Medical history review, physical examination and interpretation of echocardiography results by a consultant cardiologist, confirming or ruling out heart failure diagnosis. After this, if a patient is interested in taking part in this study, he / she will be asked to sign the consent form and perform non-invasive assessment of heart function lasting between 9-12 minutes i.e. 3-min rest, 3-min standing, and 3-6 min exercise step-test protocol.
Impact: It is expected that enhanced diagnosis of heart failure will improve current clinical practice, particularly in primary care setting, and in turn, quality and length of life of patients. It will improve referral accuracy from primary to secondary care and allow early administration of evidence-based treatment that improves patient outcomes, delays disease progression, and lead to more clinical and cost-effective healthcare pathway.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0287
Date of REC Opinion
25 Oct 2016
REC opinion
Further Information Favourable Opinion