The different projects

Non-interventional protocols (medication is not administered):
AmyloAFFECT: This questionnaire is meant to be taken during a check-up or a follow-up for heart failure. In this study, the answers from heart disease patients will be compared with those of cardiac amyloidosis patients. This aims to help doctors diagnose amyloidosis.
This questionnaire is a self-assessment so it is up to the patient to fill it out. Questions focus on symptoms, when they first appeared and the patient’s medical history. It is a very general questionnaire. This information will help us to create a diagnostic scoring system so that it will be easier to differentiate between a standard heart condition and amyloidosis. We also think this will help us to become more familiar with the different types of amyloidosis.
AmyloCOLLECT: This involves preserving blood samples which are administered with specific markers which will help us to better understand heart failure’s physiopathological mechanisms.
The study aims to show that for patients with congestive heart failure, a program designed for dietary education, managing sodium intake and preventing malnutrition will be more effective than the usual dietary advice (which usually just focuses on sodium intake) that patients receive at unscheduled hospital visits six months after.
The objectives are to:
  • Show that this new dietary education programme can improve nutrition, quality of life, practical application of dietary recommendations and the burden of being limited by a low-salt diet
  • Show how useful educational materials are in setting up the new education programme for preventing malnutrition (personalised meal plans and recipes)
  • Study the link between salt intake (prescribed and/or actual consumption) in a low-salt diet and morbimortality, the quality of life and the difficulties of being limited by a low-salt diet. This secondary objective is based on recent studies which suggest that a strict low-salt diet could be damaging (in terms of morbimortality and moderately reduced salt-intake).
  • To study the link between salt intake (prescribed and actually consumed) and energy and protein intake. The hypothesis underpinning this objective is that the stricter the low-salt diet, the weaker the balanced diet becomes if protein and energy intake are insufficient.
Inclusion criteria:
  • Chronic heart failure
  • Cardiac decompensation in the last two years
Safe Home:
This aims to show how safe and efficient home hospital visits are in comparison to standard hospitalisation for patients with chronic decompensated heart failure.
          Inclusion criteria:
  • Recurrent hospitalisation for cardiac decompensation
  • Right-sided heart failure requiring IV diuretics
  • Hospital home care within a maximum of four days after hospitalisation
  • To diagnose patients in the 48h hospitalisation period
Exclusion criteria:
Undetermined heart failure
AMYLO-CARTESIAN: This aims to evaluate the impact (morbidity and mortality) of cardiac transthyretin amyloid deposits (CA) and/or cardiac retention of diphosphonates in scintigraphs in elderly patients with aortic stenosis who have had a valve replacement.
The objectives are to:
  • Determine and compare the sensitivity and specificity of echocardiographs and MRIs when diagnosing cardiac amyloidosis.
  • Determine how prevalent wild type transthyretin cardiac amyloids are in patients with calcific aortic stenosis who have had an aortic valve replacement.
  • Start a bio-bank of blood samples and identify the biomarkers of wild type transthyretin cardiac amyloids, a sign that calcific aortic stenosis surgery or TAVI is needed.
Inclusion criteria:
  • Severe calcific aortic stenosis
  • Patient age ≥70
  • Ejection fraction ˂60% or strain rate ˃ -17%
Exclusion criteria:
  • Other serious illnesses
  • Illness which requires mitral valve surgery
  • Aortic insufficiency (class ˃III)
AMYLODEAFNESS: This study involves a hearing screening. Amyloid deposits can infiltrate different anatomical structures in the ear. Moreover, some diuretic treatments which are necessary to treat heart failure can sometimes cause hearing damage and cardiological problems can impair vascuralisation of the inner ear leading to decreased hearing. Having a better description of these anomalies could help diagnose patients with early-onset amyloidosis (particularly after a hearing check-up) and improve care for all patients with amyloidosis.
Interventional protocols (involving the administration of medication)
VICTORIA: This aims to evaluate how effectively Vericiguat, a stimulant taken orally consisting of soluble guanylate cyclase (sGC), can delay the first occurrence of the composite endpoints of death due to cardiovascular disease or hospitalisation due to heart failure in patients affected by heart failure with preserved ejection fraction receiving standard treatment, and this will be compared with a placebo.
Population: Chronic heart failure patients
Left ventricular ejection fraction ˂45%
Excludes: Amyloidosis and hypertrophic cardiomyopathy
Inclusion criteria:
  • Optimisation of standard heart failure treatment
  • Treated with diuretics administered by IV in the last 3 months or over the course of current hospitalisation
Exclusion criteria:
  • Patient has been treated with long-acting nitrates or nitric oxide donors or phosphodiesterase 5 inhibitors
  • Patient has a primary cardiac valvulopathy needing medical intervention or has had valvular intervention in the last 3 months.
  • Patient is presenting with symptoms of carotid stenosis, TIA or a stroke
GALACTIC: This aims to evaluate how OMECAMTIV MECARBIL treatment affects time elapsed before death caused by cardiovascular problems or the first instance of heart failure (whichever comes first) in patients with chronic heart failure with reduced ejection fraction receiving standard treatment. This will be compared with a placebo.
Population: Chronic heart failure
Left ventricular ejection fraction ≤35%
Excludes: Amyloidosis and hypertrophic cardiomyopathy
Inclusion criteria:
  • Optimisation of standard heart failure treatment
  • Hospitalisation for acute heart failure in the 6 months before randomisation
Exclusion criteria:
  • IV administration of inotrope or vasopressors ≤ 3 days before randomisation
  • Having an implantable cardioverter-defibrillator or recently starting cardiac resynchronisation therapy
  • Having a severe, untreated ventricular arrhythmia
  • Symptomatic bradycardia or 2nd/3rd degree heart block without a pacemaker
SERENADE: This study aims to evaluate if 10 mg of macitentan can reduce natriuretic peptide level of ‘N-terminal pro brain natriuretic peptide’ (NT-pro-BNP) in comparison with a placebo in the 24th week of patients presenting with heart failure with preserved ejection fraction and a pulmonary vascular illness.
The effect of the 10mg of macitentanin comparison to the placebo will be measured by:
  • Daily physical activity
  • Quality of life
  • The development of the heart failure
Ejection fraction ≥ 40% (no history of ejection fraction ≤ 40%)
Excludes: Amyloidosis and hypertrophic cardiomyopathy
Inclusion criteria:
  • Patients with heart failure with preserved ejection fraction
  • Patients that have had cardiac catheterisation in the last 6 months with an end-expiratory pulmonary capillary pressure or a left ventricular end-diastolic pressure of ˃15 mmHg.
OR a pulmonary vascular illness
OR impaired right ventricular function:
  1. Maximum tricuspid regurgitation speed of ˃2.8m/s or mean pulmonary arterial pressure of ≥ 25mmHg or systolic pulmonary arterial pressure ˃40mmHg and tricuspid annular plane systolic excursion ˂17mm or right ventricular fraction area change ˂35% or tissue Doppler velocity of ˂ 9.5cm/s)
  2. Diastolic pulmonary vascular pressure gradient (DPG) ˃ 5 mmHg
  3. Pulmonary vascular resistance (PVR) ˃ 3 Wood units
Exclusion criteria:
  • Severe, untreated valvulopathy
  • Indication that a transluminal angioplasty of the artery or a coronary artery bypass is needed
  • Taking treatment for pulmonary arterial hypertension in the weeks before trial selection
  • Treatment involving strong inducers or inhibitors of the isoenzyme Cytochrome P450 3A4 (CYP3A4) over the last few months
  • Patients who have had any surgical procedures
Protocols to come
This aims to test how a new medication called Tafamidis affects patients with hereditary transthyretin cardiac amyloidosis or senile hereditary cardiac amyloidosis.
This aims to test how epigallocatechin 3-gallate and doxycycline, separately or co-administered, affect changes in left ventricular longitudinal strain in the apex amongst patients with AL cardiac amyloidosis after one year.
Main parameter: to improve or at least stabilise left ventricular longitudinal strain in the apex measured by echocardiograph.
This aims to test how diflunisal and epigallocatechin 3-gallate, separately or co-administered, affect left ventricular 2D strain and interventricular septal thickening 2 years after the development of transthyretin cardiac amyloidosis.
The objectives are to:
  • Evaluate mortality and rehospitalisation rates for acute heart failure
  • Evaluate the effects that treatments have on clinical, biological and echocardiographic parameters
This aims to evaluate the effect that shiatsu (self-massage) has on symptoms of amyloidosis and the impact it has on patients’ quality of life.
This aims to estimate the number of patients with transthyretin amyloidosis in France and evaluate the uses, tolerance and effectiveness of Tafamidis.