Phase 4
N=9
Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF
Heart Failure · Heart Failure, Diastolic · Heart Failure With Preserved Ejection Fraction · Cardiac Failure · Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT04757584 ↗Enrolled (actual)
9
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Features of a Feasible and Pragmatic Protocol for Deprescribing N-of-1 Trials in Patients With Heart Failure With Preserved Ejection Fraction, as Measured by Qualitative Interview — 4; 3; 2; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Beta blockers (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Features of a Feasible and Pragmatic Protocol for Deprescribing N-of-1 Trials in Patients With Heart Failure With Preserved Ejection Fraction, as Measured by Qualitative Interview |
5; 4; 5; 3; 5; 2 | — |
| PRIMARY Features of a Feasible and Pragmatic Protocol for Deprescribing N-of-1 Trials in Patients With Heart Failure With Preserved Ejection Fraction, as Measured by Qualitative Interview |
5; 4; 5; 3; 5; 2 | — |
Summary
In this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct 16 4-period N-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. The N-of-1 trials will be iteratively refined in real-time based on this feedback.
Eligibility Criteria
Inclusion Criteria
- Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure [HF] and ejection fraction [EF] ≥50%)
- Taking Beta blocker
Exclusion Criteria
- Alternate Causes of HFpEF Syndrome:
- Severe valvular disease
- Constrictive pericarditis
- High output heart failure
- Infiltrative cardiomyopathy
- Other compelling indication for beta blocker:
- Prior EF 100 beats per minute (bpm), atrial arrhythmia with ventricular rate >90 bpm, systolic blood pressure > 160 mmHg
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Decompensated HF
- Hospitalized in past 30 days
- Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
- Estimated life expectancy <6 months
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation
Data sourced from ClinicalTrials.gov (NCT04757584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.