NORM-HF Pivotal Study (NCT07574593)
NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
🩺 Plain-English Summary (8th-Grade Level)
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in a 1:1 ratio to receive either NORM™ System and guided heart failure management (intervention group) or usual standard of care with guided heart failure management (control group).
Who can join: Review the eligibility criteria below.
Location: Cardiovascular Institute of San Diego — Chula Vista, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Cardiovascular Institute of San Diego — Chula Vista, California
- UC Davis — Sacramento, California
- University of Florida Health - Jacksonville — Jacksonville, Florida
- Baycare Health System — Tampa, Florida
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York
- Christ Hospital Lindner — Cincinnati, Ohio
- Saint Francis Health System — Tulsa, Oklahoma
- University of Pennsylvania — Philadelphia, Pennsylvania
- North Central Heart - Avera Hospital — Sioux Falls, South Dakota
📞 Contact the Study Coordinator
Phone: (617) 802-5911
Email: NORM-HF@fire1foundry.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure
- REDUCE LAP-HFREF TRIAL — New York, New York
- Physiological Effects Ketone Ester in Heart — Cleveland, Ohio
- DASH Diet in Heart Failure Outpatients — Sacramento, California
- Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients — Huntsville, Alabama
- LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System. — Birmingham, Alabama
- A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation — Alexander City, Alabama
Explore by condition: All Heart Failure clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.