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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01960218
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 Years and older
* Subject is hospitalized for acute decompensated heart failure (ADHF)
1. Systolic OR
2. Diastolic
* Subject is Stage C:Class II/III/IV heart failure
* Subject is willing and to provide appropriate informed consent
* Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule
* Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System
Exclusion Criteria:
* The subject is pregnant (verified in a manner consistent with institution's standard of care)
* Subject is currently participating in another investigational device or drug trial
* Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
* Subject is unwilling or unable to return for the required follow-up after test
* Subject has Left Ventricular Assist Device (LVAD)
* Subject is listed for transplant
* Subject has a clinical diagnosis of acute myocardial infarction (AMI) on admission (Note: If troponin measurements have been collected and are elevated but not due to an MI subject is still eligible for study)
* Subject has a pulmonary embolism (PE) on admission
* Subject is dialysis dependent
* Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study
* Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent
* Subject has severe hypertension \> 180 millimeter of mercury (mmHg) resting systolic at time of test
* Subject has severe heart failure with renal insufficiency (with Creatinine clearance rate (CrCL) of 30 or less) and/or on IV Inotropic therapy and/or enrolling in hospice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01960218
Study Brief:
Protocol Section:
NCT01960218