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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03387605
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent for the study
* Have current diagnosis of Ischemic and/or non-ischemic cardiomyopathy
* Left ventricular ejection fraction (LVEF) \< 30% by echo during the screening
* Sinus rhythm with HR ≥100 bpm
* Systolic blood pressure ≥ 90 mmHg assessed by cuff sphygmomanometer
* CI \< 2.2 L/min/m2
* Current symptom(s) of HF (New York Heart Association (NYHA) class IV) at Screening.
* Absence of hypovolemia, defined as a central venous pressure ≥10 mmHg and pulmonary capillary occlusion pressure ≥15 mmHg before administration of Dobutamine
Exclusion Criteria:
* Respiratory support with mechanical ventilation
* Circulatory mechanical support
* Atrial pacing with the presence of sick sinus syndrome or sino-atrial block
* Second or third degree atrioventricular (AV) block,
* Atrial fibrillation/flutter
* Amiodarone treatment
* Ventricular tachycardia
* Acute coronary syndrome
* Bilirubin \> 2.5
* Alanine aminotransferase (ALT) \>60 IE/L,
* Serum creatinine \>2.5 g/ml)
* Fever and significant infection
* Pregnancy
* Anemia, Hgb \< 9.0
* Patients required treated with severe cytochrome CYP3A4 inhibitors drugs Concomitant use of strong CYP3A4 inhibitors will be avoided during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03387605
Study Brief:
Protocol Section:
NCT03387605