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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT04767061
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure \[HF\] and ejection fraction \[EF\] ≥50%)
* Taking Beta blocker
Exclusion Criteria:
* Alternate Causes of HFpEF Syndrome:
1. Severe valvular disease
2. Constrictive pericarditis
3. High output heart failure
4. Infiltrative cardiomyopathy
* Other compelling indication for beta blocker
1. Prior EF \< 50%
2. Hypertrophic cardiomyopathy
3. Angina symptoms
4. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
5. History of ventricular tachycardia
6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
7. Sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmHg
* Clinical instability (N-of-1 trials are appropriate for stable conditions only)
1. Decompensated HF
2. Hospitalized in past 30 days
3. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
* Estimated life expectancy \<6 months
* Moderate-severe dementia or psychiatric disorder precluding informed consent
* Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04767061
Study Brief:
Protocol Section:
NCT04767061