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Cardiotoxicity clinical trials

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NCT ID: NCT06332131 Not yet recruiting - Melanoma Clinical Trials

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

Start date: April 2024
Phase:
Study type: Observational

This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

NCT ID: NCT06005259 Not yet recruiting - Heart Failure Clinical Trials

Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)

SPIROTOX
Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of spironolactone in the primary prevention of cardiotoxicity in cancer patients who are undergoing chemotherapy with anthracycline within 12 months. The main question it aims to answer is: • Does spironolactone reduce the incidence of cardiotoxicity in patients undergoing anthracycline chemotherapy? Participants will: - Be cancer patients over 18 years starting treatment with anthracycline; - Be randomized to receive either spironolactone or a placebo for 1 year; - Undergo assessments of their left ventricular ejection fraction (LVEF), global longitudinal strain, and cardiac biomarkers over the 12-month period. Researchers will compare the spironolactone group to the placebo group to see if cardiotoxicity incidence differs between the two.

NCT ID: NCT05521178 Not yet recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Cardiotoxicities in Patients Receiving BTKi

Start date: May 2024
Phase:
Study type: Observational

This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.

NCT ID: NCT05465031 Not yet recruiting - Breast Cancer Clinical Trials

Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)

Start date: February 2023
Phase: Phase 4
Study type: Interventional

Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril/valsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings. Therefore, the Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril/valsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on cardiac magnetic resonance imaging (MRI). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril/valsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI, electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment.

NCT ID: NCT05411250 Not yet recruiting - Clinical trials for Positron-Emission Tomography

Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

Start date: June 1, 2022
Phase:
Study type: Observational

To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.

NCT ID: NCT05377320 Not yet recruiting - Hypertension Clinical Trials

PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Start date: June 2024
Phase:
Study type: Observational

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

NCT ID: NCT05358093 Not yet recruiting - Clinical trials for Breast Cancer Female

Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Start date: April 27, 2022
Phase:
Study type: Observational

Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life . Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 . Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT . Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction. Radiotherapy also have cardio toxic effect through different mechanisms

NCT ID: NCT05298072 Not yet recruiting - Breast Cancer Clinical Trials

Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients

Start date: April 2022
Phase:
Study type: Observational

This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.

NCT ID: NCT05063643 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude

Start date: October 2021
Phase:
Study type: Observational

This is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for HER-2 positive breast cancer patients who lives in high altitude area. One hundred and thirty two HER-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. The cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. The subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.

NCT ID: NCT05040867 Not yet recruiting - Breast Cancer Clinical Trials

Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.