Trials / Completed
CompletedNCT04757584
Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF
N-of-1 Trials for Deprescribing Beta-blockers in HFpEF
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Heart Failure
- Heart Failure, Diastolic
- Heart Failure With Preserved Ejection Fraction
- Cardiac Failure
- Heart Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Beta blockers | The intervention is a two-arm crossover withdrawal/ reversal design (On \[A\] vs Off \[B\]) with up to 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued. Subjects will be randomized into either ABAB or BABA sequences. |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2023-04-28
- Completion
- 2023-04-28
- First posted
- 2021-02-17
- Last updated
- 2024-04-09
- Results posted
- 2024-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04757584. Inclusion in this directory is not an endorsement.