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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT04575428
Eligibility Criteria:
Inclusion Criteria:
* Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D), including patients on inotropic medication
* Systolic blood pressure (SBP) \> 100 mmHg
* History of HF hospitalization or ER visit or iv diuretic use in last 12 months.
* Patients will be included regardless of left ventricular ejection fraction.
Exclusion Criteria:
* Anticoagulation at the time the procedure or in case of recent warfarin use an INR \>1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at time point of procedure.
* Immunosuppressive medications for solid organ transplant
* Acute MI (STEMI or Type I NSTEMI) within 7 days?
* Evidence of progressive cardiogenic shock within 48 hours
* Restrictive cardiomyopathy
* Constrictive pericarditis
* Pericardial effusion with evidence of tamponade
* Severe valvular stenosis requiring intervention
* Known history of an increased bleeding risk
* Thrombocytopenia (\< 50,000)
* End-stage renal disease CKD stage 5 due to primary renal pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04575428
Study Brief:
Protocol Section:
NCT04575428