PREcision meDICine in Treatment in CardioVascular Disease

N/ANot Yet RecruitingNCT07369141

Maastricht University Medical Center430 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 9 months

Secondary Outcomes

Time to death from any cause

time to the first (re)hospitalization due to disease progression

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

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

Time frame: 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

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

Time to cardiovascular (CV) mortality

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

Change in QoL

Change in QoL according to the KCCQ-TSS (change from baseline in KCCQ-TSS score, measured in points, with higher scores indicating better health status.)

Time frame: 9 months

Change in NT-proBNP

Change in NT-proBNP (pg/mL)

Time frame: 9 months

Change in clinical congestion score

Change in clinical congestion score (CCS). The higher the score the worst congestion is

Time frame: 9 months

Change in eGFR

Change in eGFR (mL/min/1.73 m²)

Time frame: 9 months

GDMT at 9 month

Guideline directed Medical Therapy

Time frame: 9 months

PREcision meDICine in Treatment in CardioVascular Disease

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes