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Beta Blocker

Beta Blockers for Heart Failure (PRE-INFORMED Trial)

Phase 4

Recruiting

Led By Parag Goyal, MD, MSc

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Taking beta-blocker

Must not have

Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years

Alternate causes of HFpEF Syndrome: Severe aortic stenosis, Moderate-severe mitral stenosis, Constrictive pericarditis, High output HF, Infiltrative cardiomyopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if N-of-1 trials can help seniors with Heart Failure decide if they should stay on beta-blocker meds or not.

Who is the study for?

This trial is for adults aged 65 or older with Heart Failure with Preserved Ejection Fraction (HFpEF), who are currently taking beta-blockers and meet specific heart function criteria. People can't join if they have other heart conditions, recent severe cardiac events, certain arrhythmias, uncontrolled blood pressure, or any instability that could affect the study.

What is being tested?

The study aims to see if N-of-1 trials help patients decide whether to continue or stop using beta-blockers for HFpEF by increasing their confidence in the decision-making process.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions to beta-blockers such as fatigue, dizziness, slow heartbeat, and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 or older with heart failure but my heart still pumps well.

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I am currently taking a beta-blocker medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack or heart surgery in the last 3 years.

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My heart condition is not caused by severe valve issues, constrictive pericarditis, high output failure, or infiltrative cardiomyopathy.

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I have had episodes of very fast heartbeats.

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I have been diagnosed with thickened heart muscles.

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I experience chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient decision-confidence, as measured by the Decisional Conflict Scale (DCS)

Change in patient's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews

Secondary study objectives

Change in patient activation through an N-of-1 protocol, as assessed by the Patient Activation Measure (PAM)

Change in patient's decision effectiveness through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale

Change in patient's feeling informed through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Beta-Blocker AB SequenceActive Control1 Intervention

This arm will follow an AB sequence: ON beta-blockers (A) and OFF beta-blockers (B). Subjects start with their home dose in Period 1 (A), then switch to Period 2 (B), where the study team slowly reduces their dose until they are off their beta-blocker (or the lowest dose they can tolerate). Subjects are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Subjects 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 subject chooses to continue into Period 3 (A), the study team will restart the subject's beta-blocker, and slowly up-titrate until they reach their home dose. This continues until the subject has enough information to clarify their preference about continuing or discontinuing their beta-blocker, with a limit of 6 periods.

Group II: Beta-Blocker BA SequenceActive Control1 Intervention

This arm will follow a BA sequence: OFF beta-blockers (B) and ON beta-blockers (A). Subjects start Period 1 (B) with the study team slowly reducing the subject's beta-blocker home dose until they are off (or the lowest dose they can safely tolerate), then switch to Period 2 (A), where they restart their beta-blocker and slowly up-titrate until they reach their home dose. Subjects are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Subjects 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 subject will slowly reduce their beta-blocker dose until they are off (or the lowest dose they can safely tolerate). This continues until the subject has enough information to clarify their preference about continuing or discontinuing their beta-blocker, with a max of 6 periods.

0 / 7Eligibility criteria met