A Preliminary Study for INFORMED

Description

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

Conditions

Heart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Cardiac Failure, Heart Diseases

Study Overview

Study Details

Study overview

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

A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization

A Preliminary Study for INFORMED

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
  • 2. Taking beta-blocker
  • 1. Alternate cause(s) 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(s) for beta-blocker
  • 1. Prior EF \< 50%
  • 2. Hypertrophic cardiomyopathy
  • 3. Angina
  • 4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years
  • 5. History of ventricular tachycardia/arrhythmia
  • 6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
  • 7. Heart rate \>100 bpm within the prior 3 months
  • 8. Atrial arrhythmia with ventricular rate \>90 per minute in the prior 3 months
  • 9. Systolic blood pressure readings \>160 mmHg within the prior 3 months, unless classified as white coat hypertension (and home blood pressures below 140 mmHg)
  • 10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, glaucoma, hyperthyroidism, essential tumor reduction)
  • 3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)
  • 1. Decompensated heart failure
  • 2. Hospitalization in the past 30 days
  • 3. Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion
  • 4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
  • 5. Clinical instability from other medical issues
  • 4. Estimated life expectancy \< 6 months
  • 5. Moderate-severe dementia or psychiatric disorder precluding informed consent
  • 6. Language barrier that will preclude informed consent and ability to comprehend study procedures
  • 7. Non-compliance or inability to complete study procedures
  • 8. Enrollment in a clinical trial not approved for co-enrollment
  • 9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Parag Goyal, MD, MSc, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2026-07