PREcision meDICine in Treatment in CardioVascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 430
- 试验地点
- 4
- 主要终点
- Clinical benefit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical endpoint committee remains blinded to allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard of Care
Standard treatment for HF
干预措施: Standard of Care (Investigator Choice) (Other)
Intervention
AI algorithm to assist the treating HF professional in treatment decision
干预措施: ASSIST-HF AI- algorithm (Other)
结局指标
主要结局
Clinical benefit
时间窗: 9 months
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
次要结局
- 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)
- Change in NT-proBNP(9 months)
- Change in clinical congestion score(9 months)
- Change in eGFR(9 months)
- GDMT at 9 month(9 months)