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Cardiotoxicity clinical trials

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NCT ID: NCT05699915 Recruiting - Cancer Clinical Trials

Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors

CAVACI
Start date: January 7, 2022
Phase: N/A
Study type: Interventional

The goal of this prospective, multicentre study is to investigate short- and long-term cardiovascular effects in cancer patients treated with immune checkpoint inhibitors (ICIs). The main question[s] it aims to answer are: - To investigate troponin and NT-proBNP values in patients receiving ICIs and their association with ICI-induced CV abnormalities and MACEs. - Study the calcium score, systolic, and diastolic (dys)function. - Evaluate associations between patient/disease characteristics / transthoracic echocardiography parameters / electrocardiography parameters and troponin / NT-proBNP levels. Participants will be closely monitored by performing the following additional visits and testing: - Chest CT scan prior to treatment start, after 12 and 24 months. - Consultation with a cardiologist at baseline, 3, 6, 12 and 24 months, who will perform an electrocardiogram and echocardiogram. - One additional blood sample prior to treatment start, after 3, 6, 12 and 24 months. An extra blood sample could be taken in case of sudden heart problems. - Non-invasive endothelial function tests prior to treatment start, after 12 and 24 months.

NCT ID: NCT05598879 Recruiting - Breast Cancer Clinical Trials

Global Cardio Oncology Registry

G-COR
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.

NCT ID: NCT05559164 Recruiting - Clinical trials for Early-stage Breast Cancer

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.

NCT ID: NCT05508087 Recruiting - Cardiotoxicity Clinical Trials

Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.

Start date: July 17, 2019
Phase:
Study type: Observational

In this research we investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

NCT ID: NCT05507879 Recruiting - Breast Carcinoma Clinical Trials

TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer

Start date: August 18, 2022
Phase:
Study type: Observational

This study examines TRPC6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. Understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.

NCT ID: NCT05406635 Recruiting - Clinical trials for HER2-positive Breast Cancer

Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer

HER2BIC
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.

NCT ID: NCT05349058 Recruiting - Cardiotoxicity Clinical Trials

Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors

MIICI
Start date: January 17, 2021
Phase:
Study type: Observational [Patient Registry]

ICI's have become the first-line treatment for patients with various malignancies. Although case studies represent fulminant myocarditis, there is uncertainty in prevalence of subclinical myocardial injury induced by ICI's. In this prospective study, ICI treatment naïve patients with no significant prior cardiovascular history were enrolled. Primary outcome was the prevalence and severity of cardiac Troponin I (cTnI) at 6 weeks following ICI. Secondary outcomes were change in global longitudinal strain (GLS) and right ventricular free wall strain (RV FWS) measured by echocardiography, myocardial injury as assessed by cardiovascular magnetic resonance (CMR) and major adverse cardiac events (MACE). MACE defined as composite of cardiovascular mortality, heart failure, hemodynamically significant arrhythmias or heart block at 3 months.

NCT ID: NCT05271162 Recruiting - Cardiotoxicity Clinical Trials

Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines

EMPACT
Start date: September 30, 2023
Phase: Phase 3
Study type: Interventional

EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. The study will be carried out in accordance with GCP and monitoring will be outsourced to a subcontractor - CRO. The examination will be insured and will begin as soon as the required approvals are obtained.

NCT ID: NCT05258448 Recruiting - Cardiac Disease Clinical Trials

COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)

COLA
Start date: August 2015
Phase:
Study type: Observational [Patient Registry]

Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.

NCT ID: NCT05223413 Recruiting - Lymphoma Clinical Trials

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

RESILIENCE
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

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.