Effects of Shiatsu on Symptoms and Quality of Life in Cardiac Amyloidosis Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of three targeted Shiatsu sessions on patients with severe cardiac amyloidosis, comparing it to 'comfort' Shiatsu and no Shiatsu. The aim is to assess the short-term impact on various symptoms such as fatigue, pain, anxiety, and quality of life. The study will also measure neuro-cardiovascular physiological parameters and patient satisfaction with the Shiatsu interventions. By incorporating Shiatsu as a complementary therapy, the research seeks to improve the management of chronic symptoms associated with amyloidosis.

Why it matters

Who can join: the full rules

Inclusion 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 non-Shiatsu groups);
* Score global à l'EESE-R supérieur ou égal à 10 (groupes Shiatsu et sans shiatsu).

Exclusion Criteria:

* 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 interventional 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.

Where it's running

• Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
  Créteil, France Recruiting

Study contacts

• Study coordinator: JULIE POMPOUGNAC, Dr
• Email: julie.pompougnac@aphp.fr
• Phone: 00 33 6 35 37 61 63

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Liver and Coagulation Markers in ATTR Cardiac Amyloidosis

  This study tests liver function and blood-clotting markers in people with ATTR-CA to see if they reflect disease severity and progression.

  Recruiting University of Messina · Messina, Sicily · NCT07766135

• Cardiac Amyloidosis: See if Intracardiac Thrombi are Common on CT

  This study tests whether a contrast-enhanced cardiac CT can reliably detect intracardiac thrombi in adults with cardiac amyloidosis.

  Recruiting Centre Hospitalier Universitaire Dijon · Dijon · NCT07648303

• Higher pacemaker rate for people with cardiac amyloidosis

  This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07583823

• Using [64Cu]FBP8 PET/MR to find intracardiac blood clots in cardiac amyloidosis

  We'll test whether a [64Cu]FBP8 PET/MR scan can find blood clots inside the heart of people with cardiac amyloidosis who have atrial fibrillation or atrial flutter.

  Recruiting Phase 3 Brigham and Women's Hospital · Boston, Massachusetts · NCT07560306

• Chest pain screening for hidden cardiac amyloidosis

  We will test whether men over 65 who have chest pain but no coronary artery disease might have hidden cardiac amyloidosis using blood and urine tests, ECG and echocardiography, bone scintigraphy, and sometimes a heart biopsy.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07435168

• Using advanced heart MRI to improve diagnosis and risk prediction for rare cardiomyopathies

  This project tests whether advanced cardiac MRI techniques can help diagnose and predict future risk for people with rare heart muscle diseases like Danon, Fabry, cardiac amyloidosis, Noonan syndrome, and cardiac sarcoidosis.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07336394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.