PREcision meDICine in Treatment in CardioVascular Disease

NCT07369141 | Withdrawn DMC

• 4 other identifiers: PREDICT-CVDNo 101112022No 10088702NL 009912
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Heart Failure; Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Clinical benefit

  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, as assessed using a win ratio

  9 months

Secondary Outcomes (9)

• Time to death from any cause

  9 months (the number of days/months from randomization to the date of death)

• Time to first (re)-hospitalization due to heart failure

  9 months (the number of days/months from randomization to the date of first (re)-hospitalization due to heart failure)

• Time to all-cause hospitalization

  9 months (the number of days/months from randomization to the date of all cause hospitalization).

• Time to cardiovascular (CV) mortality

  9 months (the number of days/months from randomization to the date of CV death)

• Change in QoL

  9 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard treatment for HF

Other: Standard of Care (Investigator Choice)

Intervention

EXPERIMENTAL

AI algorithm to assist the treating HF professional in treatment decision

Other: ASSIST-HF AI- algorithm

Interventions

ASSIST-HF AI- algorithm OTHER

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

Intervention

Standard of Care (Investigator Choice) OTHER

Standard treatment of care for HF

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to understand and sign informed consent,
• Scheduled or on renal replacement therapy,
• 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,
• Scheduled for mechanical assist device or heart transplant,
• Acute coronary syndrome (ACS) in the past 3 months or current angina pectoris ≥class III,
• Requiring valvular surgery or revascularization in the upcoming 3 months or revascularization within the past 3 months,
• 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),
• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• University Medical Center Groningen: collaborator
• Maastricht University: collaborator

Study Sites (4)

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical endpoint committee remains blinded to allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept trial

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

NL (4)