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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01545102
Eligibility Criteria:
Inclusion criteria:
* Systolic heart failure with resting left ventricular ejection fraction below 40%
* New York Heart Association (NYHA) class I-III
* clinically stable for at least 4 weeks on optimised medication dosage according to current guidelines
Exclusion criteria:
* Acute coronary syndrome within past 6 months
* Untreated lifethreatening cardiac arrhythmias
* Acute heart failure (during initial period of haemodynamic instability)
* Uncontrolled hypertension
* Advanced atrioventricular block
* Acute myocarditis or pericarditis
* Symptomatic aortic stenosis
* Severe hypertrophic obstructive cardiomyopathy
* Acute systemic illness Intracardiac thrombus
* Progressive worsening of exercise tolerance of dyspnoea at rest over previous 35 days
* Significant ischaemia during low intensity exercise (\< 2 METS, \< 50W)
* Uncontrolled diabetes
* Recent embolism
* Thrombophlebitis
* New onset atrial fibrillation/flutter
* \> 1.8 kg increase in body mass over previous 13 days
* Concurrent, continuous or intermittent dobutamine therapy
* Decrease in systolic blood pressure with exercise
* NYHA Functional Class IV
* Complex ventricular arrhythmia at rest or appearing with exertion
* Supine resting heart rate \> 100 beats/min
* Patient is participating in a conflicting study, is unable to perform exercise testing
* Patient lacks the capacity to consent or cannot comply with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01545102
Study Brief:
Protocol Section:
NCT01545102