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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 measure is 76-weeks (24-week max intervention phase,1-year follow-up phase). this outcome was measured at baseline, end of period and intervention visits, and during follow-up.
Awards & highlights

Study Summary

This trial will test the impact of beta-blockers on physical function in older adults with heart failure by conducting N-of-1 trials.

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 measure is 76-weeks (24-week max intervention phase,1-year follow-up phase). this outcome was measured at baseline, end of period and intervention visits, and during follow-up.
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 measure is 76-weeks (24-week max intervention phase,1-year follow-up phase). this outcome was measured at baseline, end of period and intervention visits, and during follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Exercise Capacity When on Beta-blocker Versus When Off Beta-blocker, as Measured by Peak Oxygen Consumption (VO2) During Cardiopulmonary Exercise Test (CPET)
Change in Lower Extremity Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by the Balance Portion of a Modified Version of the Short Physical Performance Battery.
Change in Lower Extremity Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by the Chair Rise Portion of a Modified Version of the Short Physical Performance Battery.
+2 more
Secondary outcome measures
Change in Patient-reported Cognitive Function When on Beta-blocker Versus When Off Beta-blocker, as Measured by Patient-Reported Outcome Measurement Information System-Short Form 6a (PROMIS SF-6a)
Change in Patient-reported Health Status When on Beta-blocker Versus When Off Beta-blocker, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Change in Patient-reported Health When on Beta-blocker Versus When Off Beta-blocker, as Measured by the EuroQol-5D Visual Analogue System (EQ-5D VAS)
+2 more

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 and finally during Period 4, we will uptitrate 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 uptitrating until reaching their home dose and 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
1,054 Previous Clinical Trials
1,316,519 Total Patients Enrolled
9 Trials studying Heart Failure
222,852 Patients Enrolled for Heart Failure
The New York Community TrustOTHER
6 Previous Clinical Trials
1,201 Total Patients Enrolled
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this clinical experiment?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical trial, which was initially published in April 2021, is currently seeking participants. Sixteen individuals must be recruited from one site to meet the study's requirements."

Answered by AI

What health conditions are regularly treated with the Beta Blocker BABA Sequence?

"Beta Blocker BABA Sequence is generally prescribed to treat hypesthesia, however it has been known to alleviate the symptoms of various other ailments like elevated intra ocular pressure (iop), tachycardia, ventricular, and angina pectoris."

Answered by AI

What are the key aims of this clinical research endeavor?

"This trial aims to measure the variations in physical activity when a participant is taking beta-blockers and not, as measured by step count on wearable technology. Additional secondary outcomes that will be monitored over Weeks 6 and 12 include: changes in patient-reported health status (KCCQ-12), quality of life (PROMIS 29) and overall reported health (EQ 5D VAS)."

Answered by AI

How many individuals can potentially enroll in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms the validity of this medical study, which was first posted on April 1st 2021 and recently updated on June 24th 2022. The research team is recruiting 16 patients from a single location."

Answered by AI

Has the Beta Blocker BABA Sequence achieved clearance from regulatory bodies?

"Due to its approval status, Beta Blocker BABA Sequence was given a score of 3 for safety on our 1-3 scale at Power. This is because the trial in question is Phase 4, signifying it has received final regulatory clearance."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Beta-blockers on Physical Function in HFpEF
2021. "Impact of Beta-blockers on Physical Function in HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04767061.
~2 spots leftby Apr 2025
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