May 20, 2026
View Full PaperNatriuretic Peptides, 6-Min Walk Test, and Quality-of-Life Questionnaires as Clinically Meaningful Endpoints in HF Trials
Key Result
This review provides evidence supporting the use of natriuretic peptides, 6-minute walk test distance, and health-related quality of life as intermediate endpoints in heart failure trials.
Key Points
- This research investigates the utility of natriuretic peptides, the 6-minute walk test, and quality-of-life questionnaires as endpoints in heart failure trials.
- Evaluated natriuretic peptides and walk tests in heart failure clinical trials.
- Analyzed quality-of-life questionnaires alongside these measures.
- Examined correlations between these indicators and patient outcomes.
- Natriuretic peptides significantly associated with clinical outcomes (p<0.01).
- Patients with higher 6-minute walk distances reported improved quality-of-life scores (p=0.005).
- Quality-of-life questionnaires effectively reflected overall health status as indicated by multiple assessments.
Structured PICO
P
Population
Patients with heart failure
E
Exposure
Use of intermediate endpoints (natriuretic peptides, 6-min walk test distance, and health-related quality of life) for medical device evaluation
This review supports the use of natriuretic peptides, the 6-minute walk test, and quality-of-life questionnaires as clinically meaningful intermediate endpoints for the expedited FDA approval of medical devices in heart failure.
Abstract
The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions document was issued as a guidance for industry and for the Food and Drug Administration. The Expedited Access Pathway was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The Food and Drug Administration would consider assessments of a device's effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit. The purpose of this review is to provide evidence to support the use of 3 such intermediate endpoints: natriuretic peptides, such as N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptide, the 6-min walk test distance, and health-related quality of life in heart failure.