Optimizing beta-blocker use in older adults with heart failure
A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
This study is trying to see if a personalized approach to adjusting beta-blocker medication can help older adults with heart failure feel more confident in their treatment and manage their condition better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05585125 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 65 and older who have been diagnosed with HFpEF and are currently taking beta-blockers.
Not a fit: Patients with alternate causes of HFpEF or other compelling indications for beta-blocker use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients to make informed decisions about their heart failure treatment, potentially improving their quality of life.
How similar studies have performed: While the use of N-of-1 trials is a novel approach in this context, similar methodologies have shown promise in other areas of personalized medicine.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (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
Where this trial is running
New York, New York
- 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: Princess Osma, BA
- Email: pro4001@med.cornell.edu
- Phone: 646-962-8077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.