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Completed
NCT05019027
N-of-1 for Beta-Blockers in Cardiac Amyloidosis
Conditions: Cardiac Amyloidosis, Heart Diseases, TTR Cardiac Amyloidosis
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 14
Sponsor: Weill Medical College of Cornell University
Location: Weill Cornell Medicine New York New York
Summary
The study team will generate preliminary data on whether patients with cardiac amyloidosis feel better when their beta-blocker is stopped. To achieve this objective, 20 N-of-1 trials (on vs. off) will be conducted, and the study team will subsequently interview participants to better understand their outcomes. Each subject will participate in 2 periods lasting between up to 6 weeks each based on each patient's health profile. We will also engage stakeholders to understand the acceptability and feasibility of deprescribing N-of-1 trials. The N-of-1 trials will be iteratively refined in real-time based on feedback.
Eligibility Criteria
Inclusion Criteria:
1. Ambulatory adults age ≥65 years with TTR-cardiac amyloidosis (confirmed by PYP scan or biopsy)
2. Taking beta-blocker
Exclusion Criteria:
1. Other compelling indication(s) for beta-blockers:
1. Angina
2. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 years
3. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
4. Heart rate \>100 bpm within the prior 3 months
5. Atrial arrhythmia with ventricular rate \>90 beats per minute within the prior 3 months
6. Systolic blood pressure readings \>160 mmHg within the prior 1 month, unless classified as white coat hypertension/effect (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)
2. Clinical instability (N-of-1 trials are appropriate for stable conditions only)
1. Decompensated heart failure
2. Hospitalized in the past 30 days
3. Medication changes or procedures in the prior 14 days that could confound observations/data at Principal Investigator 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
3. Estimated life expectancy \
Source: ClinicalTrials.gov (NCT05019027). StuddyBuddy aggregates publicly available trial information.