The aim of this clinical study-part in the Netherlands is to identify demographic and clinical predictors of risk, diagnosis, and progression of heart failure. In the European study component, the objective is to eventually compute with this…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of the diagnostic study performed in the Netherlands is the
number of new HF diagnoses, and the demographic and clinical predictors of
risk, diagnosis and progression of HF. The risk stratification is based on
multiple elements with as key elements the MACE, hospitalization for HF or
other cardiovascular diseases, and developing HF during follow-up. Ultimately,
the DSS will be developed to predict the risk of developing HF.
Secondary outcome
Secondary clinical endpoints include:
- Quality of life measured using the Minnesota Living with Heart Failure
(MLHFQ) questionnaire and the Short Form-36 questionnaire
- Major adverse cardiovascular event (MACE), including acute myocardial
infarction, stroke, cardiovascular mortality and hospitalization for unstable
angina or revascularization procedures (26).
- Heart failure hospital admission during the follow-up period.
- Heart failure diagnosis during the follow-up period in those who at baseline
had no HF.
- Cardiac Output Response to Stress (CORS) test for HF diagnosis.
- Voice recording test for HF diagnosis.
Background summary
Heart failure (HF) is a complicated disease with low quality of life and high
healthcare costs. General Practitioners (GPs) and cardiologists have no access
to adequate risk stratification tools to further enhance their clinical
judgement on HF.
Study objective
The aim of this clinical study-part in the Netherlands is to identify
demographic and clinical predictors of risk, diagnosis, and progression of
heart failure. In the European study component, the objective is to eventually
compute with this consortium a STRATIFYHF artificial intelligence (AI)-driven
Decision Support System (DSS) and mobile application for risk prediction,
diagnosis, and progression of HF. This DSS will have partly been developed from
an analysis of retrospective data assembled over 2023-24.
Study design
The present study is a cross-sectional diagnostic study with two years
follow-up. The study population in the Netherlands consists of patients with
suspected new-onset non-acute HF who are referred to the cardiologist by their
GP. We aim to include 200 patients in the Sint Jansdal hospital in Harderwijk
over 12 months, with a follow-up period of 24 months. Patients will receive
standard care and will undergo several additional diagnostic tests at baseline
(see section on study procedures). Based on the results of these tests at
baseline, participants will fall into two groups, with and without HF.
Overall, eight clinical centers around Europe will recruit a total of 1,600
patients (200 patients per center, approximately 50% females). This study will
collect data from the following centers:
- St Jansdal Harderwijk in cooperation with the Department of General Practice
& Nursing Science of the Julius Center for Health Sciences and Primary Care,
UMC Utrecht, Utrecht;
- Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne UK;
- University Hospitals Coventry and Warwickshire, Coventry UK;
- Cambridge University Hospitals NHS Foundation Trust UK;
- University Medical Centre Regensburg, Regensburg Germany;
- Careggi University Hospital, Florence Italy;
- Institute of Cardiovascular Diseases of Vojvodina, Sremska Kamenica, Novi Sad
Serbia;
- Hospital Universitario Ramón y Cajal, Madrid Spain.
In this study, 800 patients (including those in the Netherlands, Newcastle,
Coventry, and Cambridge) will be recruited from primary care settings
individuals with suspected new-onset non-acute HF. The remaining 800 patients,
recruited from secondary care settings in Regensburg, Florence, Novi Sad, and
Madrid, will already have a diagnosis of HF. Each center has their own protocol
adjusted to national possibilities. The follow-up data will be collected at 12
and 24 months.
In the Netherlands we will collect the data in our own secure database.
Coventry University will collate and unify the data from the clinical partners,
including data from our center, into a single prospective individual patient
database (IPD) and data will be analysed using IPD (meta-)analytical
techniques. Subsequently, they will share the data with the technical partners
of the study to answer the secondary objectives. These technical partners
include Bioengineering Research and Development Center (BIOIRC) in Serbia and
Foundation for research and technology (FORTH) in Greece.
Study burden and risks
The research assessments depends solely on non-invasive and non-experimental
investigations. Therefore, the burden associated with participation will be
relatively low. Included patients after 1 year will be asked for (some)
repeated questionnaires. At 12 and 24 months follow-up for each enrolled
patient will be determined through the general practitioner and/or cardiologist
whether a hospital admission or major adverse cardiac event (MACE) has
occurred. Minors and persons with severe cognitive impairment or who are not
proficient in Dutch will not be included.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Referred from primary care to cardiologist care with new-onset non acute
heart failure
2. Age 45 years or over
3. Willing to sign informed consent
4. Able to provide written informed consent
Exclusion criteria
1. Inability to provide verbal informed consent
2. Not proficient in Dutch or having severe cognitive impairment (i.e. not
able to understand and correctly
fill in the questionnaire or informed consent)
3. Presenting with severe symptoms (hospitalisation, natriuretic peptides >
2000 ng/L)
4. Terminal cancer diagnosis, receipt of oxygen therapy, or oxygen saturation
at rest <92%
5. Recent acute coronary syndrome (within the last 60 days)
6. Severe physical disability preventing independence
7. Scheduled or implanted pacemaker or cardio-defibrillator within the last 3
months
8. Severe renal insufficiency (estimated eGFR <=15 or on dialysis)
9. Current or planned pregnancy
10. Life expectancy less than 12 months.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06377319 |
| CCMO | NL86984.041.24 |