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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01956006
Eligibility Criteria:
Inclusion Criteria:
* Advanced HF (current inpatients) with no further clinical options as defined by treating cardiologist.
* NYHA III-IV
* LVEF\<35%
* Recurrent hospitalization (\>/=3 admissions in the preceding 12 months) for HF
* On optimal tolerated medical/device therapy. Stable therapy for 48hrs.
* Age 18-85 yrs
* Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
Exclusion Criteria:
* Hypotension (BPsys\<85)
* Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate \>100).
* Severe renal impairment Cr\>250umol/L or dialysis.
* Other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
* Pregnancy or female with childbearing potential and inability to use contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01956006
Study Brief:
Protocol Section:
NCT01956006