N-of-1 for Beta-Blockers in Cardiac Amyloidosis

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Aug 17, 2021

Keywords

ClinConnect Summary

The intervention is an unblinded NIH Stage I of Behavioral Intervention Development trial, using a single-arm crossover withdrawal/reversal design (On \[A\] vs. Off \[B\]) with 2 periods, each period lasting up to 6 weeks, allowing for down-titration and washout. During the On (A) period, participants will be on their beta-blocker (or the highest dose they can safely tolerate), as previously prescribed to the subjects by their physician. During the Off (B) period, their beta-blockers will be down-titrated and subsequently discontinued (or at the lowest dose they can safely tolerate); we wil...

Gender

ALL

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 \<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