N-of-1 for Beta-Blockers in Cardiac Amyloidosis
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.
Conditions:
🦠 Cardiac Amyloidosis 🦠 Heart Diseases
🗓️ Study Start (Actual) 31 January 2024
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 16
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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 beta-blocker
    • 1. Angina symptoms
    • 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. Sinus tachycardia \>100 bpm, atrial arrhythmia with ventricular rate \>90 beats per minute, systolic blood pressure \>160 mmHg
    • 2. Clinical instability (N-of-1 trials are appropriate for stable conditions only)
    • 1. Decompensated heart failure
    • 2. Hospitalized in past 30 days
    • 3. Medication changes or procedures in the prior 14 days that could confound observations, per the Principal Investigator's discretion
    • 3. Estimated life expectancy \<6 months
    • 4. Moderate-severe dementia or psychiatric disorder precluding informed consent
    • 5. Language barrier that will preclude informed consent and ability to comprehend study procedures
    • 6. Non-compliance or inability to complete study procedures
    • 7. Enrollment in a clinical trial not approved for co-enrollment
    • 8. Any condition that, in Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
Ages Eligible for Study: 65 Years to N/A (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 August 2021
  • First Submitted that Met QC Criteria 17 August 2021
  • First Posted 24 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 March 2024
  • Last Update Posted 25 March 2024
  • Last Verified March 2024