NCT07369141

PREcision meDICine in Treatment in CardioVascular Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The PREDICT-CVD is a prospective, randomized controlled, open label, multinational trial, in which patients with HF will be randomized to either the control arm or the intervention arm. The control arm is the standard of care and the intervention arm is where an AI-derived biomarker-guided treatment algorithm will be applied, to assist the treating professional in treatment decision. Assessment of the primary endpoint will be at the 9 month onsite follow-up visit, further long-term outcomes will be collected via telephone visits every 6 months until the last subject has completed the 9 month onsite follow-up. The main objective is to demonstrate that a personalized, AI-derived biomarker-guided medication treatment algorithm that provides advice to the treating HF professional is superior to prevent clinical events and improve quality of life (QoL) when compared to patients receiving standard treatment of care. The primary outcome of the trial is a clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and or a greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 9 months, as assessed using a win ratio. The expected duration for patients will be between 9 and max 24 months from the moment of enrollment. From 9 months onwards patients will be contacted by phone every 6 months and information regarding (HF) events and concomitant medication will be collected.

Conditions

• Chronic Heart Failure
• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2026-01-27
• Last updated: 2026-04-17

Locations

4 sites across 1 country: Netherlands