Impact of Beta-blockers on Physical Function in HFpEF
Condition: Heart Failure; Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Cardiac Failure; Heart Disease
MeSH terms: Heart Failure; Heart Diseases; Heart Failure, Diastolic
Intervention: Beta blockers
Intervention description: 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.
Intervention MeSH terms: Propranolol; Metoprolol; Atenolol; Sotalol; Nadolol; Acebutolol; Carvedilol; Nebivolol; Bisoprolol; Labetalol; Pindolol; Betaxolol; Penbutolol; Adrenergic beta-Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

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:

               1. Severe valvular disease

               2. Constrictive pericarditis

               3. High output heart failure

               4. Infiltrative cardiomyopathy

          -  Other compelling indication for beta blocker

               1. Prior EF < 50%

               2. Hypertrophic cardiomyopathy

               3. Angina symptoms

               4. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery
                  in prior 3 year

               5. History of ventricular tachycardia

               6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1
                  year

               7. Sinus tachycardia > 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)

               1. Decompensated HF

               2. Hospitalized in past 30 days

               3. 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