Status:
COMPLETED
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiotoxicity
Toxicity Due to Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with an...
Detailed Description
This is a randomized, open-label pilot trial of a biomarker-guided strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be e...
Eligibility Criteria
Inclusion
- Provision of written informed consent and HIPAA authorization
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age
- Diagnosed with breast cancer or lymphoma (any subtype), planned to receive an anthracycline based chemotherapy regimen. Patients may be enrolled up to their first dose of anthracycline even if they have already received other chemotherapeutic or targeted agents as part of neo-adjuvant or adjuvant systemic therapy.
Exclusion
- Diagnosed with Stage IV breast cancer
- Uncontrolled blood pressure defined by SBP \> 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to enrollment.
- Baseline systolic blood pressure \< 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, the average SBP will be considered)
- Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Patient with prior or concurrent malignancy whose natural history of treatment, in the opinion of the investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Patient must not have any of the following
- Severe hepatic impairment, defined as serum bilirubin \> ULN, or AST or ALT \> 5.0 ULN on most recent labs prior to enrollment. Results of serum bilirubin, AST, and ALT must be checked for screening if no results available in the EMR within 28 days prior to enrollment.
- end-stage renal failure on dialysis
- hyperkalemia with a potassium \> 5.5 mEq/l on most recent labs prior to enrollment. Serum potassium must be checked for screening if no results available in the EMR within 28 days prior to enrollment.
- a history of kidney transplant
- an eGFR \< 30 ml/min/1.73m2 at most recent check prior to enrollment. Creatinine must be checked for screening if no results available in the EMR within 28 days prior to enrollment
- cardiogenic shock
- decompensated heart failure requiring the use of IV inotropic therapy
- Non-English speaking
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04737265
Start Date
March 18 2021
End Date
February 5 2025
Last Update
July 3 2025
Active Locations (3)
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1
City of Hope
Duarte, California, United States, 91010
2
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Chester County Hospital
West Chester, Pennsylvania, United States, 19380