PREcision meDICine in Treatment in CardioVascular Disease
A legfontosabb adatok
- Ki végzi
- Maastricht University Medical Center
- Hol
- Hollandia4 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Visszavonva
- Kezdés
- 2026. febr.
- Várható befejezés
- 2028. jún.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- ASSIST-HF AI- algorithm
- Standard of Care (Investigator Choice)
- A regiszteradat frissítve
- 2026. április 17.
- Miért állt le
- Despite extensive modelling, it was not possible to develop a model that had sufficient accuracy and could be readily applied in a clinical trial.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Scheduled or on renal replacement therapy,
- Requiring valvular surgery or revascularization in the upcoming 3 months or revascularization within the past 3 months,
- Scheduled for mechanical assist device or heart transplant,
- Acute coronary syndrome (ACS) in the past 3 months or current angina pectoris ≥class III,
- 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),
- Inability to understand and sign informed consent,
- 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,
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Standard of CareMár használt kezelés, összehasonlításként
Standard treatment for HF
Kezelés: Standard of Care (Investigator Choice)
- InterventionA vizsgált kezelés
AI algorithm to assist the treating HF professional in treatment decision
Kezelés: ASSIST-HF AI- algorithm
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. április 17.