Individualized Exercise Training in Cardiac Amyloidosis

N/ANot Yet RecruitingNCT07835867

Oregon Health and Science University60 enrolled

Overview

Numerous clinical trials have demonstrated that transthyretin (TTR)-directed medical therapies can reduce the rate of functional decline in patients with transthyretin cardiac amyloidosis (ATTR-CM). However, patients treated with these therapies often experience a progressive reduction in exercise capacity despite treatment. Further, no randomized controlled trials (RCTs) have assessed the effects of exercise intervention in patients with ATTR-CM receiving TTR-directed therapy.

Habitual exercise has been shown to improve longevity and reduce overall mortality. Patients with ATTR-CM routinely experience reduced exercise tolerance and functional capacity as the disease progresses. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing quantitative exercise capacity and cardiorespiratory fitness in clinical testing, and peak oxygen consumption (peak VO2) serves as one of the most powerful prognostic markers in cardiovascular health. Lower peak VO2 values are strongly correlated with adverse cardiac events and mortality in individuals with ATTR-CM, including those on contemporary therapies. While major RCTs assessing TTR silencers and stabilizers have shown a reduction in the rate of decline of functional capacity compared to placebo, patients on active therapy still experience an overall decline in functional status. Existing clinical trials have not investigated the effects of a structured exercise training protocol on preventing this functional decline in patients with ATTR-CM. This study aims to evaluate whether an individualized exercise regimen provides additive improvements in exercise capacity and quality of life for patients with ATTR-CM who are receiving background TTR-directed therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cardiac Amyloidosis

Interventions

Exercise InterventionBEHAVIORAL

A 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch to exercise.

Physical Activity HandoutBEHAVIORAL

An American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over a 3-month period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of ATTR-cardiac amyloidosis * Able to perform endurance and resistance exercise * Currently on stable dose of TTR-directed therapy, if on therapy * Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention. * Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate Exclusion Criteria: * Sustained ventricular arrhythmias or ICD shock within 6 months * Severe valvular stenosis * Pregnancy * Recent acute coronary syndrome or coronary artery bypass \< 6 months * Large pericardial effusion * Recent acute myocarditis (\< 3 months) * Recent cardiac medication changes for management of cardiomyopathy * Patients with investigational intracardiac devices

Outcomes

Primary Outcomes

Peak Oxygen Consumption (Peak VO2)

CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.

Time frame: 12 weeks

Ventilatory Efficiency (VE/VCO2 Slope)

Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.

Time frame: 12 weeks

Secondary Outcomes

Short Form - 36 (SF-36)

The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and health status.

Time frame: 12 weeks

Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)

Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.

Time frame: 12 weeks

Groningen Frailty Indicator (GFI)

The GFI is a 15-item self-report questionnaire used to determine overall frailty level across physical, cognitive, social, and psychological domains. Scores range from 0 to 15, with higher scores representing greater degrees of frailty.

Time frame: 12 weeks

Short Physical Performance Battery (SPPB)

The Short Physical Performance Battery (SPPB) is a standardized performance-based assessment of lower-extremity physical function in older adults. It consists of three components: standing balance, usual gait speed, and repeated chair-stand performance. Each component is scored from 0 to 4 points, for a total score ranging from 0 to 12, with higher scores indicating better physical function.

Central Contacts

Bradley J Petek, MD

CONTACT

503-494-6813 petek@ohsu.edu

Data from ClinicalTrials.gov

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