International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Heart Failure Trial
NCT Number: NCT06566183
Acronym: ISCHEMIA-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Coronary Artery Disease|Cognitive Impairment|Heart Failure
Interventions: PROCEDURE: Guideline-directed medical therapy (GDMT)|PROCEDURE: Coronary artery bypass grafting (CABG)|PROCEDURE: Percutaneous coronary intervention (PCI).
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-12
Completion Date: 2031-12
Locations: NYU Langone Health, New York, New York, 10016, United States|International Study Site, International Study Site, Brazil|International Study Site, International Study Site, India|International Study Site, International Study Site, Korea, Republic of|International Study Site, International Study Site, Mexico|International Study Site, International Study Site, Poland

Summary:
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).

Primary Outcome Measures: Composite Cognitive Score, A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB., Month 12|Kansas City Cardiomyopathy Questionnaire (KCCQ) Score, The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent., Month 12|Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF, Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm., Month 12
Secondary Outcome Measures: Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability, Composite calculation of the number of participants with MCI, probable dementia or persistent disability in each arm., Month 12|Composite Number of: Death or Hospitalization for HF, Composite calculation of the number of participants who die or are hospitalized for HF in each arm., Month 12|Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause, Composite calculation of the number of participants who die or are hospitalized due to CV-related causes in each arm., Month 12|Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score, The SAQ Physical Limitations and Quality of Life domain comprises 2 items of the SAQ corresponding with angina-related physical limitations and quality of life (QOL). The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges where: 0 to 24 represents poor health status, 25 to 49 represents fair status, 50 to 74 represents good status, and 75 to 100 represents excellent status., Month 12|Self-Care of Heart Failure Index (SCHFI), The SCHFI is a 39-item questionnaire assessing HF patients' performance of self-care activities related to HF, including how often they complete self-care, how likely they are to perform certain activities, and how confident they feel in performing the activities. Each item is rated on a scale from 1-5; the total score is the sum of responses and ranges from 39-195. Higher scores indicate greater overall performance of self-care activities related to HF., Month 12