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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
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
PRE-INFORMED 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.Check my eligibility
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.See study design
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.
PRE-INFORMED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or older with heart failure but my heart still pumps well.
Select...
I am currently taking a beta-blocker medication.
PRE-INFORMED Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 morePRE-INFORMED 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.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,289 Total Patients Enrolled
9 Trials studying Heart Failure
222,841 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,043 Total Patients Enrolled
42 Trials studying Heart Failure
213,295 Patients Enrolled for Heart Failure
Parag Goyal, MD, MScPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack or heart surgery in the last 3 years.My heart condition is not caused by severe valve issues, constrictive pericarditis, high output failure, or infiltrative cardiomyopathy.I have had episodes of very fast heartbeats.I was hospitalized for a heart rhythm problem in the last year.I have been diagnosed with thickened heart muscles.Your heart rate is too fast, or your blood pressure is too high.I am 65 or older with heart failure but my heart still pumps well.Your heart's pumping ability was previously measured and found to be less than 50%.I experience chest pain.I am currently taking a beta-blocker medication.I need a beta-blocker for another important health reason.
Research Study Groups:
This trial has the following groups:- Group 1: Beta-Blocker AB Sequence
- Group 2: Beta-Blocker BA Sequence
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Heart Failure Patient Testimony for trial: Trial Name: NCT05585125 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could the Beta Blocker ABAB Sequence be hazardous to human health?
"Beta Blocker ABAB Sequence has been approved, so our team rates its safety at a 3 on the scale."
Answered by AI
Are there any available vacancies for participants in this trial?
"According to the documentation on clinicaltrials.gov, this particular medical trial is no longer taking in patients. It had initially been posted on December first 2022 and was last updated October 11th of the same year. Despite not recruiting any more participants for this study, there are still 990 other trials actively searching for volunteers at present time."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
New York
Indiana
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
What site did they apply to?
Weill Cornell Medicine
Why did patients apply to this trial?
To help further understanding. I would like to learn more about my condition, and possibly to see if there are any advances that may be able to help people like me in the future.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits last? How long is the study, and what is the screening process, is there compensation for this study?
PatientReceived 2+ prior treatments
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