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Beta Blocker

Beta Blocker BABA Sequence for Heart Failure

Phase 4
Waitlist Available
Led By Parag Goyal, MD
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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial will test whether it is feasible to stop taking beta-blockers for patients with Heart Failure with Preserved Ejection Fraction. 16 patients will each do 4 periods of taking/not taking the medication, and then be interviewed about feasibility and practicality.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Trial Design

2Treatment groups
Active Control
Group I: Beta Blocker BABA SequenceActive Control1 Intervention
This arm will follow a BABA sequence. "A" representing ON beta blockers and "B" representing OFF of beta blockers. Subjects in this arm will have their previously prescribed beta blocker dose reduced until they are completely off of beta blockers during Period 1. They will then crossover into Period 2, where uptitration will begin until they are back on their previously prescribed dose of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, we will again conduct a dose reduction, until the subject is off of beta blockers. Finally, during Period 4, we will up-titrate them back to their home dose of beta blockers.
Group II: Beta Blocker ABAB SequenceActive Control1 Intervention
This arm will follow an ABAB sequence. "A" representing ON beta blockers and "B" representing OFF beta blockers. Subjects in this arm will continue their home dose during the initial A period, they will then crossover into Period 2, where dose reduction will begin until they are off of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, they will restart beta-blockers, gradually up-titrating until reaching their home dose. Finally, during Period 4, we will again conduct a dose reduction until off of beta blockers.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,134 Total Patients Enrolled
9 Trials studying Heart Failure
222,852 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,205 Total Patients Enrolled
42 Trials studying Heart Failure
213,306 Patients Enrolled for Heart Failure
Parag Goyal, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Heart Failure
9 Patients Enrolled for Heart Failure
~2 spots leftby May 2025
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