Phase 4
N=9
Impact of Beta-blockers on Physical Function in HFpEF
Heart Failure · Heart Failure, Diastolic · Heart Failure With Preserved Ejection Fraction · Cardiac Failure · Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT04767061 ↗Enrolled (actual)
9
Serious AEs
7.4%
Results posted
Jul 2023
Primary outcome: Primary: Change in Physical Activity When on Beta-blocker Versus When Off Beta-blocker, as Measured by Step Count on Wearable Activity Monitoring Device — 2790.5; 3167.3 Count of Steps
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 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity When on Beta-blocker Versus When Off Beta-blocker, as Measured by Step Count on Wearable Activity Monitoring Device |
2790.5; 3167.3 | — |
| PRIMARY Change in Lower Extremity Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by the Balance Portion of a Modified Version of the Short Physical Performance Battery. |
3.9; 3.6 | — |
| PRIMARY Change in Lower Extremity Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by the Gait Speed Portion of a Modified Version of the Short Physical Performance Battery. |
4.3; 4.6 | — |
| PRIMARY Change in Lower Extremity Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by the Chair Rise Portion of a Modified Version of the Short Physical Performance Battery. |
16; 15.1 | — |
| PRIMARY Change in Exercise Capacity When on Beta-blocker Versus When Off Beta-blocker, as Measured by Peak Oxygen Consumption (VO2) During Cardiopulmonary Exercise Test (CPET) |
10.0; 11.4 | — |
| SECONDARY Change in Patient-reported Quality of Life When on Beta-blocker Versus When Off Beta-blocker, as Measured by Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) |
39.8; 40.0; 46.8; 47.9 | — |
| SECONDARY Change in Patient-reported Sexual Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by Patient-Reported Outcome Measurement Information System-Sexual Function (PROMIS-Sexual Function) |
1.8; 2.1 | — |
| SECONDARY Change in Patient-reported Cognitive Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by Patient-Reported Outcome Measurement Information System-Short Form 6a (PROMIS SF-6a) |
53.8; 52.4 | — |
| SECONDARY Change in Patient-reported Health Status When on Beta-blocker Versus When Off Beta-blocker, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
58.7; 66.0 | — |
| SECONDARY Change in Patient-reported Health When on Beta-blocker Versus When Off Beta-blocker, as Measured by the EuroQol-5D Visual Analogue System (EQ-5D VAS) |
68.9; 67.8 | — |
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.
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 (NCT04767061). 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.