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| Name | Class |
|---|---|
| European Commission | OTHER |
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Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.
Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo baseline Cardiac Magnetic Baseline (CMR), and high sensitivity troponin (hsTn) and NT-proBNP blood test. Patients with confirmed LVEF >40% by CMR will be randomized 1:1 to RIPC vs simulated RIPC (Sham). After the third chemotherapy cycle, a second CMR+ hsTn/ NT-proBNP will be performed for the validation of the early marker of cardiotoxicity. A third hsTn/ NT-proBNP blood test will be performed in the last chemotherapy cycle. Nine weeks after finishing chemotherapy, a last CMR+ hsTn/ NT-proBNP will be performed. Patients will be followed-up for clinical events at 6, 12, 18, 30 and 42 months until the last patient undergoes the final CMR. When the last patient undergoes the third CMR, the follow-up will be closed. The median follow-up estimation for clinical endpoints is 36 months (range: 6 to 60 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Conditioning | Active Comparator | Remote Ischemic Conditioning (RIC): Patients will undergo weekly RIC during the entire span of the chemotherapy period. Each RIC session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation |
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| simulated RIPC (Sham) | Sham Comparator | Control group (Sham): Patients will undergo weekly simulated RIC (sham) during the entire span of the chemotherapy period. Each sham session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Device | The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to 200 mmHg to stop blood flow in the arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of anthracycline-induced cardiotoxicity events | Cardiotoxicity event is defined as one of the following:
UNITS: absolute number of patients in each arm qualifying for cardiotoxicity event (i.e. each patient will be qualified at the end of the study as YES/NO). | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: (RIC vs Sham) Absolute change in LVEF | change in LVEF between baseline and any follow-up CMRs, whichever shows worse LVEF UNITS: LVEF is expressed as % LVEF= (LV end-diastolic volume - LV end-systolic volume) / LV end-systolic volume), % | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
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Inclusion Criteria:
≥18 years old NHL, HL or breast cancer diagnosis Scheduled to undergo chemotherapy including ≥ 240 mg/k2 cumulative dose of anthracyclines.
Pre-chemo LVEF >40% on screening echocardiography.
Presence of ≥1 of the following risk factors for developing cardiotoxicity:
Previous coronary artery disease (any of the following):
Previous coronary revascularisation (PCI or CABG) or Medical history of previous significant nonrevascularized coronary stenosis Previous Acute Coronary Syndrome / Acute Myocardial Infarction with a LVEF > 40 LVEF 41-54% Age ≥ 65 years old Previous diagnosis of arterial hypertension (with or without treatment) Chronic kidney disease (estimated glomerular filtration rate <60ml/min/1.73m2) Current or former smoker. Obesity (BMI≥30 kg/m2) LVH on screening echocardiography (LV thickness ≥12mm). High alcohol intake (≥21 alcoholic beverages per week) Sinus rhythm on screening ECG Previous diagnosis of diabetes (except those treated with sulfonylureas or those with neuropathy) Previous non-anthracycline-based chemotherapy Signed Informed Consent Form (ICF)
Exclusion Criteria:
History of any of the following diseases:
Clinical diagnosis of diabetes neuropathy
Contraindication for CMR:
Severe thrombocytopenia (platelets <50,000/µL) on any blood test within the previous 3 months.
Patients participating in other clinical trials.
Impossibility to consent or undergo study follow-ups.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Borja Ibañez, MD PhD FESC | Contact | 914501200 | 4302 | bibanez@cnic.es |
| Noemi Escalera | Contact | 914501200 | 5401 | nescalera@cnic.es |
| Name | Affiliation | Role |
|---|---|---|
| Borja Ibañez, MD PhD FESC | CNIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Recruiting | Aarhus | Denmark |
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Randomization (1:1) will be stratified by LVEF on baseline CMR (as quantified by CMR core lab /CNIC), by research Centre and by patient's gender.
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| Simulated RIPC (Sham) | Device | The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to a low pressure not stopping blood flow in the arm. |
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| Rate of tumor regression. | Response to chemotherapy UNITS: absolute number of patients in each arm qualifying as responder or no responder (i.e. each patient will be qualified at the end of the study as YES/NO). | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
| Change in Quality of Life-Haematological Malignancy Patient-Reported Outcome Measure questionnaire | Haematological Malignancy Patient-Reported Outcome Measure (HM-PRO) questionnaire UNITS: absolute points in the questionnaire. minimum value 0 maximum value 84 the higher the total score, the better (greater the effect on a patient's QoL) | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
| Change in Quality of Life-Euro Quality of Life-5 dimensions questionnaire | Euro Quality of Life-5 dimensions (EuroQoL-5D) questionnaire: UNITS: absolute points in the questionnaire. minimum value 0 maximum value 100 the higher the total score, the better (greater the effect on a patient's QoL) | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
| Change in Quality of Life-Kansas City Cardiomyopathy Questionnaire | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) UNITS: absolute points in the questionnaire. minimum value 0 maximum value 65 the higher the total score, the better (greater the effect on a patient's QoL) | 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) |
| Rate of Heart Failure Hospitalization | Rate of Heart Failure Hospitalization UNITS: Absolute number of patients in each arm experiencing a heart failure hospitalization | 4-60 months |
| Hospital Jaques Monod, El Havre | Not yet recruiting | Montivilliers | France |
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| Henri Becquerel | Recruiting | Rouen | France |
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| University Hospital Duesseldorf UDUS | Recruiting | Düsseldorf | Germany |
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| Amsterdam UMC | Not yet recruiting | Amsterdam | Netherlands |
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| Hospital da Luz Learning Health (GLSMED) | Recruiting | Lisbon | Portugal |
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| IPO Lisboa | Recruiting | Lisbon | Portugal |
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| Hospital Universitario Príncipe de Asturias | Not yet recruiting | Alcalá de Henares | Spain |
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| Centro Medico Teknon | Recruiting | Barcelona | Spain |
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| Instituto Catalán de Oncología | Recruiting | Barcelona | Spain |
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| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Spain |
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| Centro Nacional de Investigaciones Cardiovasculares (CNIC) | Recruiting | Madrid | Spain |
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| Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | Spain |
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| Hospital Infanta Leonor | Recruiting | Madrid | Spain |
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| Hospital Puerta de Hierro | Recruiting | Madrid | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Spain |
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| Hospital Universitario Clínico San Carlos | Recruiting | Madrid | Spain |
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| Hospital Universitario la Paz | Recruiting | Madrid | Spain |
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| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | Spain |
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| Hospital Universitario Ruber Juan Bravo | Recruiting | Madrid | Spain |
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| Hospital Universitario de Salamanca | Recruiting | Salamanca | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Spain |
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| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | Spain |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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