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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02406820
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ≥ 18 years old
* Signs and symptoms of congestive heart failure including two of the following:
* Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
* Pulmonary edema or pleural effusion as seen on chest X-ray
* Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
* Willing and able to comply with the study protocol
* Willing and able to give valid Informed Consent
Exclusion Criteria:
* Pregnant patients
* Presence of Left Ventricular Assist Device (LVAD) or heart transplant
* Complex congenital heart disorder or prosthetic valve on right side
* Known mitral stenosis
* Unstable medical condition or impairment other than condition associated with HF
* Unstable hypertension
* Too unstable in the judgment of the investigator to be included in the study
* Active lung infection or acute pulmonary decompensation
* Elevated white blood cell count and signs of infection are evident
* Does not have the cognitive ability to understand and sign the Informed Consent
* Does not have the cognitive capacity to perform handgrip test
* Is not able to perform a handgrip stress test
* Is not able to wear any of the devices
* Patient's life expectancy is less than 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02406820
Study Brief:
Protocol Section:
NCT02406820