Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04551560
Eligibility Criteria:
Inclusion Criteria:
-Heart failure patients over 18 who have or will be receiving a Cardiomems implanted PAP monitor.
Exclusion Criteria:
* Patients who are unable to perform EMA or laboratory assessments due to cognitive, visual, language, or other disabilities will be excluded.
* Patients with Class IV heart failure will also be excluded, as they are already maximally decompensated, and a ceiling/floor effect would preclude effects of stress.
* Patients with conditions other than heart failure that affect PA pressures (e.g. dialysis).
* Patients with physical conditions that interfere with study participation.
* Patients non-compliant with their PAP monitoring.
* Patients with chronic opioid use will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04551560
Study Brief:
Protocol Section:
NCT04551560