Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412432
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2024-04-15
Brief Title:
Exercise Training and Rehabilitation In Cardiac Amyloidosis
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Exercise Training and Rehabilitation In Cardiac Amyloidosis ERICA-Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERICA
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
Detailed Description:
Among Systemic amyloidosis the peculiar deposition of beta-amyloid fibrils agglomerates localized in the interstitial space between the cardiomyocytes characterizes the spectrum of cardiac amyloidosis AC All AC phenotypes culminate in a progressive deterioration of cardiac compliance up to a true infiltrative cardiomyopathy with restrictive physiology Clinical presentation may vary from mildly symptomatic Heart Failure HF usually labeled and mistakenly confused as a classic Heart Failure with preserved ejection fraction HFpEF up to a severe scenario of severe cardiac decompensation with fluid overload marked shortness of breath fatigue and orthostatic hypotension Syncope may also appear due to infiltration in the conduction system leading to sinoatrial disease and atrioventricular block To date more than 30 proteins responsible for the deposition of fibrils have been identified and of these 9 have been identified as responsible for the cardiac involvement of the disease AC is determined in 98 of cases by the accumulation of monoclonal light chains of immunoglobulins AL or transthyretin ATTR the latter can occur either in its hereditary form ATTRv or in the wild-type variant ATTRwt Although AC is perceived as a rare disease standing a reported prevalence of around 1100000 inhabitants a recent metanalysis reported AC as underlying HF cause in 137 of cases varying from 151 of Heart Failure HF with preserved ejection fraction HFpEF and 113 in reduced fraction phenotype HFrEF This mismatch begets the hypothesis that AC is often underdiagnosed probably due to its challenging diagnosis the diverse spectrum of clinical presentation ranging from severely compromised clinical cases to rather silent manifestations and the absence of specific therapies for this condition making until a few years ago AC a true orphan disease This paradigm has been subverted in recent years by the emergence of tafamidis a targeted drug from amyloidosis that binds transthyretin preventing tetramer dissociation and production of amyloid Tafamidis has been successfully tested for ATTRwt-AC in a relatively large multicenter international double-blind placebo-controlled phase 3 trial the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial ATTR-ACT showing a remarkable improvement of the composite outcome of all-cause mortality and hospitalizations due to cardiovascular causes Apart from Tafamidis there are no evidence supporting the use of guideline-directed medical therapy GDMT used in classical forms of HF in ATTR-ACT On top of GDMT exercise training ET remains largely uninvestigated in AC ET consists of a multidisciplinary approach including a medical evaluation with modification of cardiovascular risk factors prescription of a physical exercise program and psychosocial evaluation and is currently recommended with the highest degree of recommendation in class I type A level in current guidelines on HF To date there are no data about the efficacy and safety of ET in AC specifically in the ATTRwt-AC We hereby present the outlines and the study protocol of the Exercise Rehabilitation and training in Cardiac Amyloidosis ERICA study whose aim is to investigate and analyze the safety and the efficacy of cardiac rehabilitation on patients with AC specifically those affected by the ATTR-wt form The present study aims to investigate and analyze through an interventional longitudinal controlled randomized design the effects of a structured program of Exercise training in patients with ATTRwt-AC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None