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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT01930734
Eligibility Criteria:
Inclusion Criteria:
* Age over 18
* Symptomatic HF with NYHA III-IV
* Left ventricular ejection fraction \< 30%
* Maximal tolerated dosage of Angiotensin receptor blocker (ARB) or Angiotensin converting enzyme inhibitor (ACEI), aldosterone antagonists and β-Blockers according to blood pressure, heart rate, renal function and potassium levels
* Prior implementation of resynchronization therapy and implantable defibrillator as indicated??
* Prior HF hospitalization in the past 12 months
* Unsatisfactory response to intravenous diuretics during hospitalization or ambulatory care.
Exclusion Criteria:
* Active ischemia
* Acute coronary syndrome or cardiac surgery within 3 months
* Hemodynamic and respiratory instability, with systolic blood pressure below 85mmHg, and oxygen saturation below 90% at rest
* Uncontrolled hypertension \>180/110 mmHg
* Contra-indication to dobutamine therapy
* Hemodialysis therapy
* Malignant ventricular arrythmias
* Drug or alcohol abuse
* Sepsis or ongoing systemic infection
* Active myocarditis
* Severe valvular stenosis
* Non-compliance
* Life-threatening extra-cardiac disease or malignancy with a life expectancy below 1 year
* Inability to sign an informed consent
* Participation in another trial during the previous 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01930734
Study Brief:
Protocol Section:
NCT01930734