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Beta-Blocker Tapering for Cardiac Amyloidosis
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 TTR-cardiac amyloidosis (confirmed by PYP scan or biopsy)
Taking beta-blocker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)
Awards & highlights
Study Summary
This trial will test how well N-of-1 trials work for slowly taking patients off of beta-blockers while monitoring their health.
Who is the study for?
This trial is for ambulatory adults aged 65 or older with TTR-cardiac amyloidosis, confirmed by specific tests, who are currently taking beta-blockers. It's not suitable for those with a life expectancy under 6 months, recent medication changes, severe heart issues in the past 3 years, certain mental health conditions, hospitalization within the last month, or any other condition that makes them unsuitable as per the investigator.Check my eligibility
What is being tested?
The study is testing whether patients with cardiac amyloidosis feel better without their usual beta-blocker medication. Participants will alternate between periods of taking and not taking their beta-blocker over two spans of up to six weeks each. The process includes interviews and stakeholder engagement to assess the approach.See study design
What are the potential side effects?
While this trial involves stopping a drug rather than starting one, potential side effects when off beta-blockers may include increased heart rate and blood pressure fluctuations. Each patient's experience may vary based on their individual health profile.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or older and have TTR-cardiac amyloidosis confirmed by a scan or biopsy.
Select...
I am currently taking a beta-blocker medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; weekly for up to 12 weeks; end of period 1 (week 2, 3, 4, 5, or 6), period 2 (week 8, 9, 10, 11, or 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The 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).
The change in patient-reported health status when on beta-blocker versus when off beta-blocker, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12).
The change in patient-reported quality of life when on beta-blocker versus when off beta-blocker, as measured by the EuroQol-5d Visual Analogue Scale.
Secondary outcome measures
Change in patient-reported quality of life when on beta-blocker, as measured by the Patient-Reported Outcome Measurement Information System-29 (PROMIS-29)
Trial Design
1Treatment groups
Experimental Treatment
Group I: On-Off SequenceExperimental Treatment1 Intervention
This arm will follow an On-Off sequence. This is the only arm in the study. Subjects will begin in the On phase (Period 1), maintaining their beta-blocker dosage as previously prescribed to the subjects by their physician. Subjects will then continue to the Off phase (Period 2) where they will down-titrate their beta-blocker by 50% each week until they are completely off the drug for a total of two weeks. At the end of Period 2, the subjects will have their End of Intervention visit in which they will determine if they would like to continue or discontinue their beta-blockers for the foreseeable future.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beta blocker
2015
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
U.S. Deprescribing Research NetworkUNKNOWN
Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,317,089 Total Patients Enrolled
Parag Goyal, MD, MScPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was in the hospital within the last 30 days.My heart cannot pump blood effectively anymore.I am 65 or older and have TTR-cardiac amyloidosis confirmed by a scan or biopsy.I am currently taking a beta-blocker medication.I experience chest pain.I have had a heart attack or heart surgery in the last 3 years.I was hospitalized for a fast heartbeat due to atrial arrhythmia in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: On-Off 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollments currently available for this experiment?
"Data on clinicaltrials.gov indicates that this research study is not currently recruiting any patients; the trial was first announced in December 1st, 2022 and last updated November 11th, 2022. Nevertheless, there are 414 other studies presently searching for participants to join their experiment."
Answered by AI
What measures have been taken to ensure the safety of individuals when utilizing this treatment?
"Our organization has given this treatment a score of 3, as Phase 4 trials are typically indicative of the drug's authorization."
Answered by AI
What are the major goals of this medical experiment?
"This trial will be monitored over several intervals, including Baseline; End of intervention Period 1 (Weeks 2, 3, 4, 5 or 6), Period 2 (Weeks 8, 9 10 11 or 12), Period 3 (Weeks 14 15 16 17 or 18) and Period 4 (Weeks 20 21 22 23 24). The aim is to observe any changes in exercise capacity measured by peak oxygen consumption levels when on beta-blockers compared to off. Secondary endpoints are assessing shifts in cognitive function via the Patient-Reported Outcome Measurement Information System Short Form 6a survey scale with higher scores symbolising worse cognition"
Answered by AI
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