NCT05019027CompletedPhase 4
N-of-1 for Beta-Blockers in Cardiac Amyloidosis
N-of-1 Trials to Promote Deprescribing in Older Adults With Transthyretin Cardiac Amyloidosis
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 17 Aug 2021
- Start date
- 31 Jan 2024
- Primary completion date
- 4 Jun 2026
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT05019027
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 14
- From 31 Jan 2024 to the primary completion date, 4 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other compelling indication(s) for beta-blockers:
- Angina
- Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 years
- Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
- Heart rate \>100 bpm within the prior 3 months
- Atrial arrhythmia with ventricular rate \>90 beats per minute within the prior 3 months
- 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)
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Decompensated heart failure
- Hospitalized in the past 30 days
- Medication changes or procedures in the prior 14 days that could confound observations/data at Principal Investigator discretion
- Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
- Clinical instability from other medical issues
Other illness
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Any condition that, in Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
Other
- Estimated life expectancy \<6 months
- Language barrier that will preclude informed consent and ability to comprehend study procedures
- Non-compliance or inability to complete study procedures
- Enrollment in a clinical trial not approved for co-enrollment
Who the study is looking for
- Ambulatory adults age ≥65 years with TTR-cardiac amyloidosis (confirmed by PYP scan or biopsy)
- Taking beta-blocker
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.