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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)
Must not have
Impairment from stroke, injury or other medical disorder that precludes participation in the intervention
Dementia that precludes ability to participate in exercise and follow study protocols
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can walk 4 meters on my own and take care of myself.
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I have heart failure, need diuretics, and my BNP levels are high.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any conditions like a stroke that would stop me from joining the study.
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I do not have dementia affecting my ability to exercise or follow study instructions.
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I have had an organ transplant.
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I have a severe narrowing of my heart's aortic valve.
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I do not have a terminal illness with a life expectancy of less than 1 year.
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I have a type of amyloidosis that is not ATTR.
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I have neuropathy caused by a TTR mutation.
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My kidney function is very low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
peak oxygen consumption (VO2)
Secondary study objectives
Kansas City Cardiomyopathy Questionnaire
Lower extremity function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,666 Previous Clinical Trials
11,840,195 Total Patients Enrolled

Media Library

Exercise Training Clinical Trial Eligibility Overview. Trial Name: NCT05797857 — N/A
Amyloid Cardiomyopathy Research Study Groups: Intervention arm
Amyloid Cardiomyopathy Clinical Trial 2023: Exercise Training Highlights & Side Effects. Trial Name: NCT05797857 — N/A
Exercise Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797857 — N/A
~27 spots leftby Jun 2029
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