NIH-funded research U01 cooperative agreement

A clearer symptom questionnaire for chronic heart failure

Official title: Psychometric Analyses and Quantitative Study Report for Qualification of the Chronic Heart Failure Symptom Scale (CHF-SS) (DDT COA #000112)

Funded at Critical Path Institute · NIH-11181657 · Data updated 2026-11-12

This project checks whether a new questionnaire clearly captures symptoms experienced by people living with chronic heart failure.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionCritical Path Institute
NIH-funded
Lab location1 site (Tucson, United States)
Project startSeptember 1, 2024
Project endAugust 31, 2026
Funding year2025
Award (this year)$248,278
NIH project number5U01FD008423-02
Project IDNIH-11181657 on NIH RePORTER

Who could benefit from this research

Could help

People living with chronic heart failure who experience symptoms such as shortness of breath, fatigue, swelling, or sleep problems are the intended participants.

Less likely to help

People without chronic heart failure or those only experiencing brief, acute heart issues are unlikely to benefit directly from this project.

What this research studies

If you have chronic heart failure, you might be asked to complete the CHF-SS questionnaire and possibly take part in brief interviews or online surveys. The team will combine patient responses with existing clinical trial and registry data and apply statistical (psychometric) tests to see which questions work well. They will look at how consistent the answers are, whether the questions match real symptoms, and whether the measure can detect meaningful change over time. The results will be compiled into a quantitative report to support using the questionnaire in drug development.

Why it matters

Potential benefit: If successful, the CHF-SS could provide a trusted way to capture symptoms that matter to patients and help guide better treatments and trials.

How similar studies have gone: Other heart-failure patient-reported questionnaires have been used in trials, but this effort follows newer FDA guidance and aims to produce stronger, qualification-ready evidence.

Where this research is happening

  • Critical Path Institute
    Tucson, United States
    Active

Researchers

  • Principal investigator: Mattera, Maria — Critical Path Institute
  • Study coordinator: Mattera, Maria

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.