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NOT YET RECRUITING

NCT07369141

PREcision meDICine in Treatment in CardioVascular Disease

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

Summary

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2026-02

Completion Date

2028-06

Last Updated

2026-01-27

Healthy Volunteers

Conditions

Chronic Heart Failure Acute Decompensated Heart Failure

Interventions

OTHER

ASSIST-HF AI- algorithm

AI-derived biomarker-guided treatment algorithm to assist the treating HF professional in treatment decision

OTHER

Standard of Care (Investigator Choice)

Standard treatment of care for HF

Inclusion Criteria: 1. Provide written and dated informed consent for participation prior to trial admission, 2. Age ≥18 years, female or male 3. Diagnosis of heart failure\* either before discharge of a heart failure hospital admission or in the outpatient setting, 4. Symptomatic, defined as NYHA class II - IV, 5. LVEF \< 50% measured in the last 12 months (using any modality), with no occurrence of HF event(s) since that measurement) and 6. 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. Exclusion Criteria: 1. Inability to understand and sign informed consent, 2. Scheduled or on renal replacement therapy, 3. Clearly documented intolerance to BBs, ARNI, SGLT2i or MRAs 4. Diagnosis of acute myocarditis or (non)obstructive hypertrophic cardiomyopathy, 5. The presence of a mechanical assist device, 6. Scheduled for mechanical assist device or heart transplant, 7. Acute coronary syndrome (ACS) in the past 3 months or current angina pectoris ≥class III, 8. Requiring valvular surgery or revascularization in the upcoming 3 months or revascularization within the past 3 months, 9. Anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks, 10. Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year), 11. Participation in another (intervention) clinical trial (registry studies not included) until the onsite EoS visit (V5) at 9 months has been completed. 12. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.

Locations (4)

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands