Recruiting

INFORMED

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05585125

Conditions

Heart Failure

Heart Failure, Diastolic

Heart Failure With Preserved Ejection Fraction

Cardiac Failure

Heart Diseases

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Beta blocker

Beta blocker

Study Details

Brief summary:

Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

Conditions

Heart Failure

Heart Failure, Diastolic

Heart Failure With Preserved Ejection Fraction

Cardiac Failure

Heart Diseases

Study ID

NCT05585125

Start date

Feb 7, 2024

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
2. Taking beta-blocker

Exclusion Criteria:

1. Alternate cause(s) of HFpEF Syndrome:

1. Severe aortic stenosis
2. Moderate-severe mitral stenosis
3. Constrictive pericarditis
4. High output HF
5. Infiltrative cardiomyopathy
2. Other compelling indication(s) for beta-blocker

1. Prior EF < 50%
2. Hypertrophic cardiomyopathy
3. Angina
4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years
5. History of ventricular tachycardia/arrhythmia
6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
7. Heart rate >100 bpm within the prior 3 months
8. Atrial arrhythmia with ventricular rate >90 per minute in the prior 3 months
9. Systolic blood pressure readings >160 mmHg within the prior 3 months, unless classified as white coat hypertension/effect (and home blood pressures below 140 mmHg)
10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)
3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)

1. Decompensated heart failure
2. Hospitalization in the past 30 days
3. Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion
4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
5. Clinical instability from other medical issues
4. Estimated life expectancy < 6 months
5. Moderate-severe dementia or psychiatric disorder precluding informed consent
6. Language barrier that will preclude informed consent and ability to comprehend study procedures
7. Non-compliance or inability to complete study procedures
8. Enrollment in a clinical trial not approved for co-enrollment
9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Beta-Blocker ABAB Sequence

This arm will follow an ABAB sequence: ON beta-blockers (A) and OFF beta-blockers (B). Participants start with their home beta-blocker dose in Period 1 (A), and then switch to Period 2 (B), where the dose is slowly reduced until they are off their beta-blocker (or the lowest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information to make a preference. These extra phases follow the same ON-OFF pattern (ABABAB), meaning if the participant chooses to continue into Period 3 (A), the study team will restart the participant's beta-blocker, and slowly up-titrate until they reach their home dose, or their highest tolerable dose. This continues until the participant has enough information to clarify their preference about their beta-blocker, with a limit of 6 periods.

active comparator: Beta-Blocker BABA Sequence

This arm will follow a BABA sequence: OFF beta-blockers (B) and ON beta-blockers (A). Participants start Period 1 (B) by slowly reducing the participant's beta-blocker home dose by 50% each week until they are off (or the lowest tolerable dose), then switch to Period 2 (A), where they restart their beta-blocker and slowly up-titrate until they reach their home dose (or the highest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information. The extra phases follow the same OFF-ON pattern (BABABA), meaning if they choose to continue into Period 3 (B), the participant will slowly reduce their beta-blocker until they are off (or the lowest tolerable dose). This continues until the participant has enough information to clarify their preference about their beta-blocker, with a max of 6 periods.

Interventions

Beta blocker

The intervention is a two-arm crossover withdrawal/reversal design (On \[A\] vs Off \[B\]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose).

Participants will be randomized into either ABAB or BABA sequences.

Other names:

acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol

Beta blocker

The intervention is a two-arm crossover withdrawal/reversal design (On \[A\] vs Off \[B\]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose).

Participants will be randomized into either ABAB or BABA sequences.

Other names:

acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol

Primary outcome measure

  • Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews [ Time Frame: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks. ]
  • Change in participant decision-confidence, as measured by the Decisional Conflict Scale (DCS) [ Time Frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks. ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Parag Goyal, MD, MSc

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Propranolol
  • Metoprolol
  • Atenolol
  • Sotalol
  • Nadolol
  • Acebutolol
  • Carvedilol
  • Nebivolol
  • Bisoprolol
  • Labetalol
  • Pindolol
  • Betaxolol
  • Penbutolol
  • Adrenergic beta-Antagonists
  • Adrenergic Antagonists
  • Adrenergic Agents
  • Neurotransmitter Agents
  • Molecular Mechanisms of Pharmacological Action
  • Physiological Effects of Drugs
  • Anti-Arrhythmia Agents
  • Antihypertensive Agents
  • Vasodilator Agents
  • Sympatholytics
  • Autonomic Agents
  • Peripheral Nervous System Agents
  • Adrenergic beta-1 Receptor Antagonists

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-21.