Cardiac Management of Patients With Thalassemia Minor and Breast Cancer

Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05960214

Acronym

AQUA

Enrollment

Registered

2023-07-25

Start date

2020-01-01

Completion date

2023-06-30

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Heart Diseases, Thalassemia Minor

Keywords

Cardiotoxicity, Cancer treatment related cardiac dysfunctions

Brief summary

This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only. Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.

Detailed description

Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months): 1. Physical examination findings (as pretibial edema, jugular venous distension, lung rales), 2. Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography, 3. Any changes in (N terminal) NT-ProBNP and troponin, 4. Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer, 5. Applied medications, were extracted and will be evaluated.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with diagnosis of breast cancer, and thalassemia minor, 2. \>18 years old, 3. Referred by oncologist for cardiac evaluation. 4. Patients with available cardiac evaluations data at baseline and during breast cancer treatment

Exclusion criteria

1. Patients without diagnosis of breast cancer, and thalassemia minor, 2. \<18 years old, 3. Patients without any cardiac evaluations at baseline, and during cancer treatment. 4. Patients with history of any cardiotoxic treatment prior to enrolment.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of any rise in NT-ProBNP	From enrollment to 12 months	NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any rise in troponin	From enrollment to 12 months	Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any reduction in LV	From enrollment to 12 months	Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.

Countries

Turkey (Türkiye)

Outcome results