Impact of Beta-blockers on Physical Function in HFpEF

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Cardiac Failure; Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Heart Failure; Heart Disease

Treatments: Drug: Beta blockers

Study type: Interventional

Funder types: Other

Identifiers

NCT04767061

P19-000458 (Other Grant/Funding Number)

19-10020922-02

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Beta Blocker ABAB Sequence

Active Comparator group

Description:

This arm will follow an ABAB sequence. "A" representing ON beta blockers and "B" representing OFF beta blockers. Subjects in this arm will continue their home dose during the initial A period, they will then crossover into Period 2, where dose reduction will begin until they are off of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, they will restart beta-blockers, gradually uptitrating until reaching their home dose and finally during Period 4, we will again conduct a dose reduction until off of beta blockers.

Treatment:

Drug: Beta blockers

Beta Blocker BABA Sequence

Active Comparator group

Description:

This arm will follow a BABA sequence. "A" representing ON beta blockers and "B" representing OFF of beta blockers. Subjects in this arm will have their previously prescribed beta blocker dose reduced until they are completely off of beta blockers during Period 1. They will then crossover into Period 2, where uptitration will begin until they are back on their previously prescribed dose of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, we will again conduct a dose reduction, until the subject is off of beta blockers and finally during Period 4, we will uptitrate them back to their home dose of beta blockers.

Treatment:

Drug: Beta blockers