Health TrialsbyHealthPanel

Exercise Training in Transthyretin Cardiac Amyloidosis

ConditionsAmyloid CardiomyopathyTransthyretin Cardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorBrigham and Women's Hospital

About this trial

Transthyretin cardiac amyloidosis causes debilitating heart failure in older adults. The proposed research will develop a personalized exercise training program to improve functional capacity in patients on optimal treatment for transthyretin cardiac amyloidosis. This is a vital next step to improve functional capacity and quality of life of people suffering from transthyretin cardiac amyloidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis and typing of ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity (exception: nonamyloid control arm in aim 1).

Diagnosis of heart failure, with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) (≥450 pg/ml).

Peak VO2 <80% predicted, indicating impaired aerobic capacity (for aim 2 only).

Taking tafamidis (for aim 2 only)

Disqualifiers

Acute myocardial infarction (Note: given that cardiac biomarkers such as troponin are frequently elevated in ATTR-CM patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone)

>70% obstructive coronary artery disease

Severe aortic valve stenosis

Already actively participating in formal, facility-based cardiac exercise

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise Training

    Other intervention

    A supervised, personalized exercise training program, which will consist of two 60-minute exercise training sessions per week.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

peak oxygen consumption (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. An increase of \> 1.0 ml/kg/min is considered a clinically meaningful increase

Time frame
12 weeks

Secondary outcomes

1

Kansas City Cardiomyopathy Questionnaire

Kansas City Cardiomyopathy Questionnaire (KCCQ) is a quality of life questionnaire. This will be recorded at baseline, 4-weeks and 12-weeks. The change in KCCQ score from baseline to 12 weeks is a secondary outcome. KCCQ scores are scaled from 0 to 100; where 0 denotes the lowest reportable health status and 100 the highest. An increase of 5 points is considered a clinically meaningful increase.

Time frame
12 weeks
2

Lower extremity function

The short physical performance battery (SPPB) is an assessment of lower extremity function. The change in SPPB score from baseline to 12 weeks is a secondary outcome. This is a scale of 0-12, where 0 denotes the worst performance and 12 the highest. An increase of 1 point is considered a clinically meaningful increase.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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