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D066126: Cardiotoxicity

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug3128 Prototype swab Wiki 1.00
drug1042 Control swab Wiki 1.00
drug851 Cardiac rehabilitation Wiki 1.00

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (0)


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Clinical Trials

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There is one clinical trial.


1 Randomized Controlled Trial on Comprehensive Exercise-based Cardiac Rehabilitation Programs for the Prevention of Anthracyclines and/or Anti-HER2 Antibodies-induced Cardiotoxicity in Breast Cancer

This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants will be randomly allocated to cardiac rehabilitation (intervention group) or conventional management with physical exercise recommendation (control group).

NCT03964142
Conditions
  1. Cardiotoxicity
  2. Cardiac Rehabilitation
Interventions
  1. Other: Cardiac rehabilitation
MeSH:Cardiotoxicity

Primary Outcomes

Description: Fall of 10 absolute percentage points of left ventricular ejection fraction with final value below 53% or global longitudinal strain fall >15% with respect to baseline

Measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography

Time: Baseline to every 3 months through study completion, at the end of the study at an average of 18 months, and every year after study completion up to a maximum of 5 years

Secondary Outcomes

Description: Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst posible result) to a maximum of 146 (best possible result).

Measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire

Time: Baseline and at the end of the study at an average of 18 months

Description: Significant cardiovascular and non-cardiovascular adverse effects during treatment, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions

Measure: Change in tolerance to chemotherapy: number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study

Time: Every 3 months during study completion and at the end of the study at an average of 18 months

Description: Change in functional capacity assessed by conventional ergometry, cardiopulmonary exercise test or the 6-minute walking test (6MWT) (metabolic equivalents: METs or peak oxygen consumption: VO2) * . *Due to COVID-19 pandemic, participants' assessment with CPET had to be stopped for safety concerns. In such cases, functional capacity was estimated from the maximum work rate in the 6-minute walking test (6MWT). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes, which is well correlated with VO2. The 6MWT has been proved to be valid and reliable for functional capacity assessment in the study population.

Measure: Change in global functional capacity assessed by conventional ergometry, cardiopulmonary exercise testing (CPET) or the 6-minute walking test (6MWT).

Time: Baseline and at the end of the study at an average of 18 months

Description: Number of repetitions in the sit-to-stand test within 30 seconds

Measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test

Time: Baseline and at the end of the study at an average of 18 months

Description: Range of degrees in shoulder movement measured by goniometry

Measure: Change in shoulder functional capacity assessed by range of degrees in shoulder movement by goniometry

Time: Baseline and at the end of the study at an average of 18 months

Description: Kilograms by dynamometry of right and left upper limbs

Measure: Change in upper limb strength measured by dynamometry (kg)

Time: Baseline and at the end of the study at an average of 18 months

Description: Score achieved in the SPADI (shoulder pain and disability index) questionnaire. The pain dimension consists of five questions regarding the severity of an individual's pain, functional activities are assessed with eight questions. Each question may be scored from 0 to 10. Verbal anchors for the pain dimension are 'no pain at all' (0) and 'worst pain imaginable' (10) ,and those for the functional activities are 'no difficulty' (0) and 'so difficult it required help' (10). The scores from both dimensions are averaged to produce a total score ranging from 0 (best) to 100 (worst).

Measure: Change in shoulder pain and disability assessed by the SPADI (shoulder pain and disability index (SPADI) questionnaire

Time: Baseline and at the end of the study at an average of 18 months

Description: Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status

Measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors

Time: Baseline and at the end of the study at an average of 18 months

Description: Height measured in cm

Measure: Change in anthropometric parameters: height in cm

Time: Baseline and at the end of the study at an average of 18 months

Description: Weight measured in kg

Measure: Change in anthropometric parameters: weight in kg

Time: Baseline and at the end of the study at an average of 18 months

Description: Weight and height will be combined to report BMI in kg/m^2

Measure: Change in anthropometric parameters: body mass index (BMI) in kg/m^2

Time: Baseline and at the end of the study at an average of 18 months

Description: Abdominal perimeter measured with a tape measure in cm

Measure: Change in anthropometric parameters: abdominal circumference in cm

Time: Baseline and at the end of the study at an average of 18 months

Description: Resting heart rate by pulse oximetry (beats per min)

Measure: Change in resting heart rate measured by pulse oximetry (beats per min)

Time: Baseline and at the end of the study at an average of 18 months

Description: Resting blood pressure by sphyngomanometer in mmHg

Measure: Change in resting blood pressure (mmHg) measured by sphygmomanometer

Time: Baseline and at the end of the study at an average of 18 months

Description: Value of NT-ProBNP(pg/mL) in blood tests

Measure: Change in biomarkers NT-ProBNP

Time: Baseline and at the end of the study at an average of 18 months

Description: Value of troponin I (ng/mL) in blood tests

Measure: Change in biomarkers: troponin

Time: Baseline and at the end of the study at an average of 18 months

Description: Value of haemoglobin (g/dL) in blood tests

Measure: Change in biomarkers: haemoglobin

Time: Baseline and at the end of the study at an average of 18 months

Description: Validated questionnaire to assess adherence to Mediterranean diet, including 14 questions regarding dietary habits, rated with 0 or +1 points. Global score is calculated by summing points and ranges from 0 to 14, with higher score representing higher adherence.

Measure: Change in dietary pattern as assessed by the PREDIMED (PREvención con DIeta MEDiterránea) questionnaire

Time: Baseline and at the end of the study at an average of 18 months

Description: Score achieved in the depression subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Depression scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater depression. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).

Measure: Change in the score for depression assessed by Zigmond and Snaith questionnaire to rate anxiety and depression

Time: Baseline and at study completion at an average of 18 months, plus at the end of training (at an average of 12 to 15 months) in the intervention group

Description: Score achieved in the anxiety subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Anxiety scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater anxiety. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).

Measure: Change in the score for anxiety assessed by the Zigmond and Snaith questionnaire to rate depression and anxiety

Time: Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention group

Description: Minutes of In- and out-of-hospital dedicated physical activity

Measure: Change in physical activity (minutes of dedicated physical activity)

Time: Baseline and at study completion at an average of 18 months

Description: Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).

Measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)

Time: Baseline and at study completion at an average of 18 months

Description: Perimeter of the upper limb by cirtometry (cm), stage and grade as defined by the Spanish Society of Rehabilitation and Physical Medicine

Measure: Change in lymphedema assessed by perimeter of the upper limb by cirtometry (cm), stage and grade

Time: Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months)

Other Outcomes

Description: Number of training sessions attended / number of sessions planned

Measure: Adherence and compliance to cardiac rehabilitation program (intervention group) assessed by number of training sessions attended/ number of sessions planned

Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 months

Description: Adverse events during training

Measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (intervention group)

Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 months

Description: Program-related expectations at baseline and at the end of the program' are collected through an open question "What do you expect to achieve by participating in the program?" Responses regarding expectations will be categorized by the evaluator within the following areas: psychological sphere and/or social sphere and/or physical sphere. Global expectations of benefit are scored from 0 (no benefit) to 10 (highest benefit).

Measure: Changes in expectations regarding the cardiac rehabilitation program assessed by a questionnaire (intervention group)

Time: Baseline and at the end of the cardiac rehabilitation program at an average of 12 to 15 months

Description: Satisfaction at the end of the program is assessed by a questionnaire including 9 questions concerning comfort with training sessions, training spaces and development of the program, which are scored from 0 (worse posible result) to 10 (best posible result). Total score is calculated by adding for each question, and ranges from 0 to 90. * Due to the introduction of telematic exercise training during COVID-19 pandemic, questions were slightly modified to include assessment of satisfaction with this training modality.

Measure: Satisfaction with the cardiac rehabilitation program assessed by a questionnaire (intervention group)

Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook