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Completed

NCT Number: NCT04757584

Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF

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.

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Key information

Conditions

Heart Failure Cardiac Failure Cardiovascular Diseases Heart Disease Heart Diseases Heart Failure With Preserved Ejection Fraction Heart Failure, Diastolic

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 50%
  • Hypertrophic cardiomyopathy
  • Angina symptoms
  • Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
  • History of ventricular tachycardia
  • Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
  • 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)
  • 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

Treatment and study plan

beta blockers

Drug

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.

Other names: atenolol, betaxolol, bisoprolol, metoprolol, nebivolol, nadolol, propranolol, acebutolol, penbutolol, pindolol, carvedilol, labetalol, sotalol, metoprolol succinate, metoprolol tartrate

Primary outcomes

  1. Features of a Feasible and Pragmatic Protocol for Deprescribing N-of-1 Trials in Patients With Heart Failure With Preserved Ejection Fraction, as Measured by Qualitative Interview

    Time frame: Baseline

    Qualitative interviews were conducted to assess the feasibility and acceptability of deprescribing N-of-1 trials and participant experiences. Directed content analysis methods were used to develop relevant categories and themes from interview transcript data. Transcripts were coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders was established.

  2. Features of a Feasible and Pragmatic Protocol for Deprescribing N-of-1 Trials in Patients With Heart Failure With Preserved Ejection Fraction, as Measured by Qualitative Interview

    Time frame: The maximum amount of time a subject could have been assessed for this outcome measure is 6 times across 36 weeks. This outcome was measured at each end of period visit (weeks 6, 12, 18, 24, 30) and at the end of intervention (weeks 12, 18, 24, 30, or 36)

    Qualitative interviews were conducted to assess the feasibility and acceptability of deprescribing N-of-1 trials and participant experiences. Directed content analysis methods were used to develop relevant categories and themes from interview transcript data. Transcripts were coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders was established. The outcome measure data is the cumulative count of subjects who identified categories and themes from interview transcript data collected during the span of the outcome measure time frame, up to 6 times over 36 weeks.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

N-of-1 Trials for Deprescribing Beta-blockers in HFpEF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2021
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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