Exercise Training and Rehabilitation In Cardiac Amyloidosis

NCT06412432 | Enrolling By Invitation DMC

• 1 other identifier: ERICA562023CRCA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Notwithstanding the dramatic improvement associated with Tafamidis in Heart Failure (HF) due to wild-type transthyretin cardiac amyloidosis (ATTRwt-CA), remarkable morbidity and mortality still burden this disease. Exercise training (ET) is a first-line recommended treatment for unselected HF patients, whose effects on ATTRwt-CA form remain however unexplored. The investigators hereby present rationale and design of the Exercise training and Rehabilitation in Cardiac Amyloidosis (ERICA) study, whose aim is to determine whether a tailored, supervised ET program might improve exercise capacity in HF due to ATTRwt-CA. This interventional, controlled study will randomize ATTRwt-CA patients into a control group (C) and a primary training group (ET-1). After 12 weeks, patients in group C will be offered to undergo the same ET program (ET-2) for further 12 weeks, considering the last observation as baseline. Primary endpoint will be the distance obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment in pooled ET-1 and ET-2 groups compared to C. Quality of life, peak oxygen consumption, left and right heart architecture and function, natriuretic peptides will be secondary endpoints. This study will be the first testing the effects of ET in patients with ATTRwt-CA.

Conditions

Cardiac Amyloidosis

Keywords

Cardiac Amyloidosis; wild-type transthyretin; Exercise Training; Rehabilitation; Cardiomyopathies; Heart Failure

Outcome Measures

Primary Outcomes (1)

• distance obtained at the 6-minute walk test (6MWD)

  distance (meters) obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment treatment in pooled ET-1 and ET-2 groups compared to No-ET.

  Baseline and after 12-weeks of treatment

Secondary Outcomes (16)

• N terminal pro brain natriuretic peptide (NT-pro BNP) serum levels

  Baseline and after 12-weeks of treatment

• Troponin serum levels

  Baseline and after 12-weeks of treatment

• Galectin-3 serum levels

  Baseline and after 12-weeks of treatment

• Transthyretin serum levels

  Baseline and after 12-weeks of treatment

• Quality of life assessment

  Baseline and after 12-weeks of treatment

Study Arms (2)

Exercise training

EXPERIMENTAL

Patients will undergo exercise training, nutritional advice, smoking cessation, lipid profile evaluation, control and management of body weight and abdominal circumference; evaluation of the drug therapy in progress; psycho-social evaluation.

Other: Exercise training (ET1+ET2)

Controls

ACTIVE COMPARATOR

control group who won't undergo exercise training and will be managed with optimal medical therapy

Behavioral: Optimal Medical Therapy (No-ET)

Interventions

Exercise training (ET1+ET2) OTHER

Exercise training will consist of continuous aerobic training of moderate intensity on cycle ergometer/treadmill, with a frequency of 2-3 weekly sessions lasting 12 weeks, with exercise intensity of VO2 peak of 40% gradually increasing up to 50-60% of VO2 peak based on individual tolerability and improvement; 55-65% of heart rate at peak; 40-59% of heart rate reserve; 4-6 Metabolic equivalents (METS); the duration of the session will gradually increase from 15-30 min to 45-60 min.

Exercise training

Optimal Medical Therapy (No-ET) BEHAVIORAL

Patients will be handled according to optimal medical therapy

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older
• Established ATTRwt diagnosis
• Heart Failure diagnosis
• Informed consent according to Italian regulations

You may not qualify if:

• Unstable Angina
• Acutely decompensated Heart Failure within 1 month before enrollment
• Occurrence of complex ventricular arrhythmias
• Presence of intracavitary thrombus
• recent (\< 1 year) thrombophlebitis with or without pulmonary embolism
• Severe obstructive cardiomyopathies
• Severe or symptomatic aortic stenosis
• Uncontrolled inflammatory or infectious diseases
• Any musculoskeletal conditions preventing physical exercise

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Translational Medical Sciences

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Cardiomyopathies; Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alberto M. Marrra, Md,PhD

  Department of Translational Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients enrolled will be handled in the outpatient's clinic of Cardiometabolic Rehabilitation Program of the Federico II University Hospital of Naples for exercise training and cardiac rehabilitation intervention. Patients will be randomized in blocks to two groups. Specifically, the primary intervention (ET-1) and the control group who won't undergo exercise training (No-ET). Following baseline assessments of both groups at baseline, the ET-1 group will be subjected to exercise training program of 2 weekly sessions for 12 weeks. After 12 weeks, both groups will be reassessed and patients belonging to group No-ET will be offered to undergo the same ET program for further 12 weeks. Those who will accept will join the secondary training group (ET-2). Primary endpoint will be the distance obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment in pooled ET-1 and ET-2 groups compared to No-ET.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 14, 2024
• Study Start: January 10, 2024
• Primary Completion: January 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)