All > Heart Failure With Preserved Ejection Fraction > Congestive Heart Failure

Beta Blocker ABAB Sequence for Heart Failure

Weill Cornell Medicine, New York, NY
Heart Failure+4 More ConditionsBeta blocker - Drug
Eligibility
65+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Diastolic Heart Failure
  • Heart Failure
  • Heart Disease

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

1
As needed rate control
1
Group I Beta-Hydroxy-Butyrate
1
Bumetanide 1.25 mg

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline, End of each period (approx. weeks 6, 12, 18, and 24), month 6 follow-up, month 9 follow-up, and month 12 follow-up

Week 12
Change in patient decision-confidence, as measured by the Decisional Conflict Scale (DCS)
Week 24
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
Change in patient's feeling supported through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Change in patient's feeling uncertainty through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Change in shared decision making through an N-of-1 protocol, as measured by the 9-item Shared Decision-Making Questionnaire
Month 12
Change in patient's confidence regarding the decision to continue or discontinue beta-blocker, as assessed by qualitative interviews
Month 12 follow-up
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 interviews

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
As needed rate control
1
Group I Beta-Hydroxy-Butyrate
1
Bumetanide 1.25 mg

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Beta Blocker ABAB Sequence
1 of 2
Beta Blocker BABA Sequence
1 of 2

Active Control

20 Total Participants · 2 Treatment Groups

Primary Treatment: Beta Blocker ABAB Sequence · No Placebo Group · Phase 4

Beta Blocker ABAB Sequence
Drug
ActiveComparator Group · 1 Intervention: Beta blocker · Intervention Types: Drug
Beta Blocker BABA Sequence
Drug
ActiveComparator Group · 1 Intervention: Beta blocker · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, end of each period (approx. weeks 6, 12, 18, and 24), month 6 follow-up, month 9 follow-up, and month 12 follow-up

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,228 Total Patients Enrolled
40 Trials studying Heart Failure
213,069 Patients Enrolled for Heart Failure
Weill Medical College of Cornell UniversityLead Sponsor
1,007 Previous Clinical Trials
1,330,922 Total Patients Enrolled
8 Trials studying Heart Failure
221,694 Patients Enrolled for Heart Failure
Parag Goyal, MD, MScPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently taking beta-blocker medication.

Who else is applying?

What state do they live in?
New York33.3%
Ohio33.3%
Massachusetts16.7%
Other16.7%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?
075.0%
125.0%
What site did they apply to?
Weill Cornell Medicine100.0%
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"
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?"
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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