Dexrazoxane for Preventing Heart Failure
(PHOENIX1 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byHui-Ming Chang, MD,MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Arkansas
Disqualifiers: Pregnancy, Cardiac disease, Renal disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing if Dexrazoxane can protect the heart from damage caused by the cancer drug Doxorubicin. Dexrazoxane is a heart-protecting agent approved to reduce heart damage from Doxorubicin. Volunteers will receive one dose of Dexrazoxane. The study will measure how well the drug breaks down a specific protein in the blood that might be linked to heart damage.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications.
Is dexrazoxane safe for humans?
Dexrazoxane is generally considered safe for humans and is used to protect the heart from damage caused by certain cancer treatments. Studies have shown it does not increase the risk of secondary cancers in children with acute lymphoblastic leukemia and helps prevent heart problems in adults undergoing chemotherapy.
12345How does the drug Dexrazoxane differ from other heart failure treatments?
Dexrazoxane is unique because it is primarily used to protect the heart from damage caused by certain cancer treatments, rather than directly treating heart failure itself. This makes it different from other heart failure drugs that focus on improving heart function or reducing symptoms.
678910Eligibility Criteria
This trial is for healthy women aged 18-65 who are not pregnant, not breastfeeding, and have no current illnesses. It's not open to those with a history of kidney or heart disease, or who are currently ill.Inclusion Criteria
Not pregnant
I do not have any current illnesses.
I am a woman.
+2 more
Exclusion Criteria
I have a history of kidney disease.
I have a history of heart disease.
Pregnancy
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one dose of dexrazoxane at varying dosages to study its effect on Topoisomerase 2b degradation
1 day
1 visit (in-person)
Follow-up
Participants are monitored for degradation of Topoisomerase 2b and 2a in blood samples
48 hours
Blood samples collected
Participant Groups
The study is testing if Dexrazoxane given early can prevent heart damage caused by Doxorubicin, a drug used in cancer treatment. The focus is on preventing heart failure in patients receiving Doxorubicin.
5Treatment groups
Experimental Treatment
Group I: Dexrazoxane 500mg/m2Experimental Treatment1 Intervention
one dose of 500 mg/m2
Group II: Dexrazoxane 400mg/m2Experimental Treatment1 Intervention
one dose of 400mg/m2 dexrazoxane
Group III: Dexrazoxane 300mg/m2Experimental Treatment1 Intervention
one dose of 300mg/m2 dexrazoxane
Group IV: Dexrazoxane 200mg/m2Experimental Treatment1 Intervention
one dose of 200mg/m2 dexrazoxane
Group V: Dexrazoxane 100mg/m2Experimental Treatment1 Intervention
one dose of 100mg/m2 dexrazoxane
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arkansas for Medical SciencesLittle Rock, AR
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Who Is Running the Clinical Trial?
University of ArkansasLead Sponsor
References
Evaluation of dexrazoxane effect on preventing acute cardiac arrhythmia in patients with breast cancer treated with neoadjuvant/adjuvant anthracycline-based chemotherapy. [2022]Adding dexrazoxane to the treatment during neoadjuvant/adjuvant anthracycline-based chemotherapy in patients with breast cancer prevents the development of heart failure. In this study, we investigated whether dexrazoxane has a protective effect on arrhythmia resulting from chemotherapy.
Dexrazoxane in the prevention of doxorubicin-induced cardiotoxicity. [2017]To review doxorubicin-induced cardiotoxicity and to evaluate the use of dexrazoxane in its prevention.
Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane. [2022]Dexrazoxane is a drug used to prevent anthracycline-induced cardiotoxicity. A recent report found an association between the use of dexrazoxane and the risk of developing secondary malignant neoplasms (SMNs) in children with Hodgkin's disease. We report the absence of an association of SMNs in children with acute lymphoblastic leukemia (ALL) treated on Dana-Farber Cancer Institute ALL Consortium Protocol 95-01.
Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. [2013]Dexrazoxane (DZR) is a clinically approved agent for preventive treatment of doxorubicin-induced cardiotoxicity. The objective of this study was to investigate the cardioprotective effects of DZR in a rat model of myocardial infarction (MI).
Upfront dexrazoxane for the reduction of anthracycline-induced cardiotoxicity in adults with preexisting cardiomyopathy and cancer: a consecutive case series. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Cardiotoxicity associated with anthracycline-based chemotherapies has limited their use in patients with preexisting cardiomyopathy or heart failure. Dexrazoxane protects against the cardiotoxic effects of anthracyclines, but in the USA and some European countries, its use had been restricted to adults with advanced breast cancer receiving a cumulative doxorubicin (an anthracycline) dose > 300 mg/m2. We evaluated the off-label use of dexrazoxane as a cardioprotectant in adult patients with preexisting cardiomyopathy, undergoing anthracycline chemotherapy.
The treatment of heart failure. A methodological review of the literature. [2018]In this article literature concerning the major drugs used in the treatment of heart failure is reviewed. Because of major discrepancies in results from short term and uncontrolled studies versus long term randomised control trials, only the latter group of studies are addressed in detail. Of 3 randomised control trials of digoxin, 1 has been positive, and 2 negative. Digoxin is probably of benefit to a minority of heart failure patients. Four randomised control trials of oral nitrates have shown a reduction in left ventricular filling pressure, and trends favouring active treatment for the indices of exercise capacity and functional status. Of 2 randomised control trials of hydralazine one is totally negative, the other difficult to interpret because of major loss of patients to followup. Of 5 trials of quinazolone derivatives (prazosin and trimazosin), 2 have been positive, 2 showed non-statistically significant trends favouring active treatment, and 1 was completely negative. These results are consistent with a modest benefit of prazosin and trimazosin in some heart failure patients. Five trials of angiotensin-converting enzyme inhibitors (captopril and enalapril) have shown dramatic and consistent benefit in exercise capacity and functional status. These results support a clinical policy of initial treatment with diuretics and addition of either captopril or enalapril for patients who remain symptomatic on optimal diuretic therapy. A trial of digoxin is warranted in patients whose functional capacity remains reduced on this regimen.
Effects of candesartan on the development of a new diagnosis of diabetes mellitus in patients with heart failure. [2021]Diabetes is a risk factor for heart failure, and both conditions are increasing. Identifying treatments that prevent both conditions will be clinically important. We previously reported that candesartan (an angiotensin receptor blocker) reduces cardiovascular mortality and heart failure hospitalizations in heart failure patients (CHARM: Candesartan in Heart Failure-Assessment of Reduction in Mortality and Morbidity Program).
Treatment with 24 hour istaroxime infusion in patients hospitalised for acute heart failure: a randomised, placebo-controlled trial. [2021]Label="AIM">Istaroxime is a first-in-class agent which acts through inhibition of the sarcolemmal Na+ /K+ pump and activation of the SERCA2a pump. This study assessed the effects of a 24 h infusion of istaroxime in patients hospitalised for acute heart failure (AHF).
Istaroxime, a first in class new chemical entity exhibiting SERCA-2 activation and Na-K-ATPase inhibition: a new promising treatment for acute heart failure syndromes? [2021]Acute heart failure syndromes (AHFS) are associated with the rapid onset of heart failure (HF) signs and symptoms. Hospitalizations for AHFS continue to rise and are associated with significant mortality and morbidity. Several pharmacological agents are currently approved for the treatment of AHFS, but their use is associated with an increase in short-term mortality. There is a need for new agents that can be given in the acute setting with increased efficacy and safety. Istaroxime is a unique agent with both inotropic and lusitropic properties which is currently being studied for the treatment of AHFS. Istaroxime inhibits the sodium-potassium adenosine triphosphatase (ATPase) and stimulates the sarcoplasmic reticulum calcium ATPase isoform 2 (SERCA-2) thereby improving contractility and diastolic relaxation. Early data from human studies reveal that istaroxime decreases pulmonary capillary wedge pressure (PCWP) and possibly improves diastolic function without causing a significant change in heart rate (HR), blood pressure, ischemic or arrhythmic events. Most commonly reported side effects were related to gastrointestinal intolerance and were dose related. In conclusion, istaroxime is a novel agent being investigated for the treatment of AHFS whose mechanism of action and cellular targets make it a promising therapy. Further studies with longer infusion times in patients with hypotension are required to confirm its efficacy and safety.
[Effect of angiotensin II receptor antagonist on heart failure]. [2021]An angiotensin II receptor antagonist, candesartan has been shown to improve left ventricular dysfunction and exercise tolerance. The assessment of response to candesartan heart failure in Japan(ARCH-J) is a randomized, double-blind, placebo-controlled 6-month study enrolled 305 patients who has not been previously treated with ACE inhibitors, who had not been adequately controlled with ACE inhibitors or who were intolerant of ACE inhibitors. The incidence of confirmed progression of heart failure was significantly lower in the candesartan group(7.4%) than in the placebo group(22.2%), with risk reduction 63.8. Cardiovascular events were also significantly lower during treatment with candesartan than with placebo(10.8% vs 22.9%) with risk reduction of 50.2%. ARCH-J study showed that candesartan cilexetil, 8 mg/day, significantly improved the progression of heart failure when compared with placebo.