A Preliminary Study for INFORMED

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigators will determine whether N-of-1 trials, as a pragmatic, patient-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased subject confidence regarding the decision to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute on Aging (NIA)
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

• Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)

• Taking beta-blocker

Exclusion Criteria:

1. Alternate causes of HFpEF Syndrome:

1. Severe aortic stenosis

2. Moderate-severe mitral stenosis

3. Constrictive pericarditis

4. High output HF

5. Infiltrative cardiomyopathy

2. 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 years

5. History of ventricular tachycardia

6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year

7. Sinus tachycardia > 100 bpm, atrial arrhythmia with ventricular rate > 90 bpm, systolic blood pressure > 160 mmHg

3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)

1. Decompensated heart failure

2. Hospitalization in past 30 days

3. Medication changes or procedures in prior 14 days that could confound observations/data, at PI discretion

4. Estimated life expectancy < 6 months

5. Moderate-severe dementia or psychiatric disorder precluding informed consent

6. Any condition that, in the Principal Investigator's opinion, makes the patient unsuitable for study participation