Optimizing beta-blocker use in older adults with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of N-of-1 trials as a personalized approach to optimize beta-blocker medication in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF). It employs a crossover design where participants will alternate between taking their prescribed beta-blocker and a reduced or discontinued dose over multiple periods. The goal is to assess whether this method can enhance participants' confidence in their medication choices and improve their overall management of heart failure. A total of 20 participants will be enrolled, each undergoing individual trials to gather data on their responses to medication changes.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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/effect (and home blood pressures below 140 mmHg)
   10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, 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

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Parag Goyal, MD, MSc — Weill Medical College of Cornell University
• Study coordinator: Srikar Savaram, BS
• Email: pro4001@med.cornell.edu
• Phone: 646-962-7919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.