Purpose of this Study
24-month enrollment period and up to 5 years of follow-up.
Who Can Participate?
Eligibility
People can join this study if they have a type of heart failure called Class II or Class III, which means they have some symptoms but can still do many daily activities. They must be taking stable heart failure medicines that follow standard medical guidelines. This means their treatment plan has not changed recently and is based on common care used by doctors.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a system called the NORM System to help care for people with heart failure. People in the study will be placed into one of two groups by chance. One group will use the NORM System, which measures fluid in the body to help guide treatment decisions. The other group will receive usual care without this system.
The goal of the study is to see if using the NORM System helps reduce worsening heart problems and lowers the risk of death related to heart disease compared to standard care.
Locations
Other
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
Principal Investigator
Marat
Fudim
Protocol Number
PRO00120167
NCT ID
NCT07574593
Phase
III
Enrollment Status
Pending Open to Enrollment