PREcision meDICine in Treatment in CardioVascular Disease
Key facts
- Who runs it
- Maastricht University Medical Center
- Where
- Netherlands4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Feb 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ASSIST-HF AI- algorithm
- Standard of Care (Investigator Choice)
- Record updated
- 17 April 2026
- Why it stopped
- Despite extensive modelling, it was not possible to develop a model that had sufficient accuracy and could be readily applied in a clinical trial.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Provide written and dated informed consent for participation prior to trial admission,
- Age ≥18 years, female or male
- Diagnosis of heart failure* either before discharge of a heart failure hospital admission or in the outpatient setting,
- Symptomatic, defined as NYHA class II - IV,
- LVEF < 50% measured in the last 12 months (using any modality), with no occurrence of HF event(s) since that measurement) and
- Those not previously treated with evidence-based therapies or sub-optimally treated with GDMT defined as; • Not treated with one of the foundational four** HF medication unless absolute contraindication or documented intolerance; Definition of heart failure according to the most recent Heart Failure Guidelines of the European Society of Cardiology; Foundational four heart failure medication: BBs, ARNi, MRAs and SGLT2i. NB. This does not include ACE and ARBs these are permitted
Who cannot take part
- Scheduled or on renal replacement therapy,
- Requiring valvular surgery or revascularization in the upcoming 3 months or revascularization within the past 3 months,
- Scheduled for mechanical assist device or heart transplant,
- Acute coronary syndrome (ACS) in the past 3 months or current angina pectoris ≥class III,
- Anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks,
- Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year),
- Inability to understand and sign informed consent,
- Clearly documented intolerance to BBs, ARNI, SGLT2i or MRAs
- Diagnosis of acute myocarditis or (non)obstructive hypertrophic cardiomyopathy,
- The presence of a mechanical assist device,
- Participation in another (intervention) clinical trial (registry studies not included) until the onsite EoS visit (V5) at 9 months has been completed
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The main goal of PREDICT-CVS is to demonstrate that a personalized, AI-derived biomarker-guided medication treatment algorithm that provides advice to the treating professional is superior to prevent clinical events and improve quality of life (QoL) when compared to patients receiving standard treatment of care.
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Participants will be randomized into two groups
* Group 1 - Standard treatment Participant will receive the usual treatment for heart failure, based on current medical guidelines. * Group 2 - AI-supported treatment The professional will receive a personalized treatment plan generated by the AI program. This plan is based on medical information and biomarkers. The professional can choose whether or not to follow the AI's advice, reasons for not following the AI-based advice will be collected.
Participants will visit the outpatient clinic at 1, 2, 3 and 9 months after being randomized.
The 2 groups in the trial
- Standard of CareExisting treatment, for comparison
Standard treatment for HF
Treatment: Standard of Care (Investigator Choice)
- InterventionTreatment being tested
AI algorithm to assist the treating HF professional in treatment decision
Treatment: ASSIST-HF AI- algorithm
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 17 April 2026