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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT07298993
Eligibility Criteria:
Inclusion Criteria:
1. Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
2. Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position)
3. Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
4. Kaiser Permanence Northern California Membership
Exclusion Criteria:
1. Alternative etiologies of HFpEF syndrome
2. Compelling guideline indication for ß-blocker:
* Prior EF \<50% (i.e., based on the structured data field on transthoracic echocardiogram)
* Current anginal symptoms (i.e., based on the Rose Angina single-question screener for angina)
* MI (i.e., diagnostic codes) and/or coronary revascularization (i.e., procedure codes) within 3 years
* Hospitalization for a primary discharge diagnosis of atrial fibrillation or atrial flutter in the prior 12 months
* Other documented reason in the opinion of the treating provider and/or enrolling clinician-investigator
3. Evidence of recent decompensated HF
* Hospitalization for a primary discharge diagnosis of HF within the past 30 days
* Change in loop diuretic pharmacy prescription in the past 30 days (i.e. pharmacy prescription data) (Note: This definition is based on documented prescription changes and does not include short-term dose adjustments that were verbally communicated to the patient by their provider.)
4. Estimated life expectancy \<6 months (i.e., diagnostic codes)
5. Diagnosed dementia (i.e.., diagnostic codes)
6. Unable to provide informed consent
7. Loss of Kaiser Permanence Northern California Membership
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07298993
Study Brief:
Protocol Section:
NCT07298993