Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Torbjorn Omland
With
University Hospital, Akershus
Oslo University Hospital
University Hospital of North Norway
St. Olavs Hospital
Helse Stavanger HF
Klinbeforsk
Norwegian Cancer Society
Novartis
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Women with histological evidence of invasive early breast cancer scheduled for adjuvant therapy with anti-cancer regimens that include anthracyclines
Eastern Cooperative Oncology Group performance status 0-1
Sinus rhythm
You may not be if
Age \<18 years
Renal failure, i.e. serum creatinine greater than 133 mol/L (1.5mg/dL) or estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2
Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L
Systolic blood pressure \< 100 mgHg
Uncontrolled hypertension
Acute myocardial infarction within the last three months
Contraindication to ACEI or ARB or sacubitril/valsartan, including previous hypersensitivity reaction, angioedema and renal artery stenosis
ACEI, ARB, aldosterone antagonist or sacubitril/valsartan use within 4 weeks of study start
Clear indication for ACEI, ARB, aldosterone antagonist or sacubitril/valsartan therapy, including symptomatic heart failure
History of hemodynamically significant valvular disease
Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
Participation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 halflives of enrollment, whichever is longer
Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
Contraindication or inability to undergo CMR examination
Fertile women with inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. Fertile women are defined as following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
Life expectancy \< 12 months
Clareo Health | Prevention of Cardiac Dysfunction During Breast Cancer Therapy
