Population Gap for Chronic Heart Failure Patients Between Randomized Controlled Trials and Japan's Super-Aged Society

Area of Science:

• Cardiology
• Geriatrics
• Clinical Trials

Background:

• Guideline-directed medical therapy (GDMT) has improved heart failure (HF) management.
• The applicability of major randomized controlled trial (RCT) findings to real-world, super-aged populations, like Japan's, is uncertain.

Purpose of the Study:

• To assess the eligibility of chronic HF patients in a super-aged Japanese society for major RCTs.
• To compare outcomes between eligible and ineligible HF patients based on RCT exclusion criteria.

Main Methods:

• Analysis of the KUNIUMI registry, a prospective observational study of chronic HF patients on Awaji Island, Japan.
• Determination of patient eligibility and exclusion percentages for six major HF RCTs (PARADIGM-HF, PARAGON-HF, DAPA-HF, DELIVER, EMPEROR-Reduced, EMPEROR-Preserved).
• Comparison of 3-year incidence of cardiovascular death and HF hospitalization between eligible and ineligible patient groups.

Main Results:

• Significant percentages of patients were excluded from major HF RCTs: PARADIGM-HF (48.4%), DAPA-HF (36.4%), EMPEROR-Reduced (42.7%), PARAGON-HF (57.9%), DELIVER (32.3%), and EMPEROR-Preserved (31.4%).
• Patients excluded from RCTs had a significantly poorer prognosis (higher risk of cardiovascular death and HF hospitalization) compared to eligible patients (P<0.05).

Conclusions:

• A substantial gap exists between HF patients in major RCTs and those in Japan's super-aged society.
• Further research is needed to provide evidence for GDMT effectiveness in real-world, elderly HF populations.