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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT03871803
Eligibility Criteria:
Inclusion Criteria:
* Stable symptomatic patients with heart failure and preserved ejection fraction (NYHA class II-III).
* NT-proBNP \>125 pg/mL in the last month
* Previous treatment with beta-blockers during the last 3 months
* Documented chronotropic incompetence, defined as: \[(heart rate at peak exercise- heart rate at baseline)\] / \[(220 - age) - (heart rate at baseline)\] \< 0.62
Exclusion Criteria:
* Moderate to severe valvulopathy or miocardiopathy associated
* Patient with heart failure with recovered ejection fraction
* Acute Coronary Syndrome in the previous 12 months
* Angina or signs of myocardial ischemia on cardiopulmonary exercise testing
* Baseline heart rate\>75 bpm.
* Uncontrolled hypertension, defined as \>140mmHg systolic blood pressure and/or \>90 mmHg diastolic blood pressure.
* Moderate to severe pulmonary disease associated
* Extracardiac comorbidity with a life expentancy less than 1 year.
* Unable to perform an adequate cardiopulmonary exersice test
* Previous treatment with digitalis or calcium channel blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03871803
Study Brief:
Protocol Section:
NCT03871803