Trials / Completed
CompletedNCT04767061
Impact of Beta-blockers on Physical Function 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
The purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.
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
- 2022-04-28
- Completion
- 2023-04-28
- First posted
- 2021-02-23
- Last updated
- 2023-09-08
- Results posted
- 2023-07-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04767061. Inclusion in this directory is not an endorsement.