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:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT02358603
Eligibility Criteria:
Inclusion criteria for the case group:
* Patient is greater than 18 years of age and less than 70 years of old.
* Patient is willing and able to give informed consent.
* Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance.
* New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients.
* Patients can perform moderate exercise.
* Left ventricular ejection fraction less than 55% but greater than 35%.
Inclusion criteria for the control group:
* Subject is greater than 18 years of age and less than 70 years of old.
* Subject is willing and able to give informed consent.
Exclusion criteria for the case group:
* Patient is unable or unwilling to sign the patient informed consent.
* Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device.
* Patient has at least one pacemaker, ICD or CRT indications.
* Patients has persistent atrial fibrillation (AF).
* Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM).
* Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ECG ST-segment shift \> 2mm at the resting.
* New York Heart Association Class IV.
* Less than 45 days after myocardial infarction.
* Less than 3 months after acute heart failure.
* Patient has uncontrolled hypertension.
* Patient is pregnant.
* Patient has a medical condition that would limit study participation.
* Patient is enrolled in a concurrent study that may affect the outcome of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02358603
Study Brief:
Protocol Section:
NCT02358603