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Exercise Training for Amyloid Cardiomyopathy
N/A
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to walk 4 meters (with or without the use of an assistive device) and independent with basic activities of daily living at the time of enrolment
Diagnosis of heart failure, with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) (≥450 pg/ml)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial aims to create a personalized exercise program to help improve the quality of life for people with transthyretin cardiac amyloidosis, a form of heart failure.
Who is the study for?
This trial is for older adults with transthyretin cardiac amyloidosis who can walk and are independent in daily activities. They must be on stable medical treatment, not already doing regular intense exercise, and have heart failure symptoms with a specific biomarker level. People with certain other health conditions or devices like pacemakers that limit exercise aren't eligible.Check my eligibility
What is being tested?
The study aims to create a personalized exercise program for patients with transthyretin cardiac amyloidosis to improve their ability to perform physical tasks and enhance life quality. Participants will follow this tailored exercise regimen while being monitored for its effects on their heart condition.See study design
What are the potential side effects?
Since the intervention involves an exercise training program, potential side effects may include muscle soreness, fatigue, shortness of breath during activity, and increased risk of falls or injuries related to physical exertion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk 4 meters on my own and take care of myself.
Select...
I have heart failure, need diuretics, and my BNP levels are high.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
peak oxygen consumption (VO2)
Secondary outcome measures
Kansas City Cardiomyopathy Questionnaire
Lower extremity function
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,908 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any conditions like a stroke that would stop me from joining the study.I can walk 4 meters on my own and take care of myself.Your ability to take in oxygen during exercise is less than 80% of what is expected for someone like you.You have more than 70% blockage in your coronary arteries.I do not have dementia affecting my ability to exercise or follow study instructions.I have had an organ transplant.I have heart failure, need diuretics, and my BNP levels are high.My heart and lung test showed something that needs more checks.Currently taking part in organized, facility-based heart exercise programs.I have a severe narrowing of my heart's aortic valve.I do not have a terminal illness with a life expectancy of less than 1 year.I have a type of amyloidosis that is not ATTR.You have a ventricular assist device.I have neuropathy caused by a TTR mutation.I am currently taking tafamidis.I have been clinically diagnosed with a recent heart attack.You have been regularly doing intense exercise for at least 30 minutes, twice a week, for the past 6 weeks.My heart condition is confirmed by a biopsy or a specific heart scan.My kidney function is very low.You have a pacemaker or implantable cardioverter-defibrillator (ICD) that cannot be adjusted to accommodate expected changes in heart rate during exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
Awards:
This trial has 1 awards, including:- 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.
Could those who have not yet reached the age of 50 participate in this medical study?
"This medical study is accepting patients between the ages of 60 and 90 years old."
Answered by AI
What criteria must be met to participate in this clinical trial?
"Patients aged between 60 and 90 with amyloid cardiomyopathy can be inducted into this trial, which is only accepting forty qualified individuals."
Answered by AI
Is this research endeavor currently recruiting participants?
"Data hosted on clinicaltrials.gov suggests that this medical trial, which first opened for recruitment on September 1st 2023, is no longer active. However, there are 258 other investigations actively recruiting participants presently."
Answered by AI
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