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New treatment option for Cardiac Amyloidosis
Official title Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
ClinicalTrials.gov ID: NCT06197165
What this study is testing
- What it's testing
- The objective of this study is to assess the beneficial effects of three targeted Shiatsu sessions compared to "comfort" Shiatsu on symptoms in patients with severe cardiac amyloidosis. Specifically, the study aims to evaluate the short-term impact of a targeted Shiatsu session on neuro-cardiovascular physiological parameters and symptoms in patients with cardiac amyloidosis, in comparison to comfort Shiatsu and no Shiatsu.
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years ;
- Patient with :
- Transthyretin of genetic origin (TTR) ;
- Transthyretin of non-mutated origin (WT) ;
- Light Chain (AL);
You likely can't join if
- Patients with orthostatic hypotension;
- Patients with bullous amyloidosis (fragile skin);
- Patients who have already received Shiatsu treatment;
- Patient with insufficient autonomy to maintain sitting position;
- Patient with insufficient autonomy to move from home to hospital;
- Participating in another treatment study, or within the exclusion period of a previous study, if applicable;
See the full eligibility criteria
- Age ≥ 18 years ;
- Patient with :
- Transthyretin of genetic origin (TTR) ;
- Transthyretin of non-mutated origin (WT) ;
- Light Chain (AL);
- Membership of a social security scheme, beneficiary or beneficiary's beneficiary (excluding AME);
- Written patient consent.
- Score greater than or equal to 3 on the EESE-R questionnaire (Edmonton Symptom Evaluation Scale-Revised), for at least 1 symptom among: dyspnea, digestive disorders, nausea, pain, anxiety, depression (Shiatsu and...
- Score global à l'EESE-R supérieur ou égal à 10 (groupes Shiatsu et sans shiatsu).
- Patients with orthostatic hypotension;
- Patients with bullous amyloidosis (fragile skin);
- Patients who have already received Shiatsu treatment;
- Patient with insufficient autonomy to maintain sitting position;
- Patient with insufficient autonomy to move from home to hospital;
- Participating in another treatment study, or within the exclusion period of a previous study, if applicable;
- Known pregnancy or breast-feeding;
- Patient under known guardianship at the time of inclusion;
- Patient under AME.
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.