Intensive Blood Pressure Control for Cardiotoxicity in Cancer Patients
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Cardiac comorbidity, Stroke, Renal failure, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.
The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on blood pressure treatment strategies rather than specific medications.
What data supports the effectiveness of the Intensive Approach to Treating High Blood Pressure in cancer patients?
Research shows that using a combination of drugs to control high blood pressure is often necessary and effective, especially in patients with other health conditions like heart failure. This approach can help achieve better blood pressure control, which is important for improving heart health.
12345Is intensive blood pressure control safe for cancer patients?
Intensive blood pressure control in cancer patients is generally considered safe, but it requires careful management because many cancer treatments can cause or worsen high blood pressure. Monitoring and managing blood pressure is important to prevent complications and ensure the best outcomes for cancer treatment.
678910How does the Intensive Approach to Treating High Blood Pressure differ from other treatments for cardiotoxicity in cancer patients?
The Intensive Approach to Treating High Blood Pressure is unique because it focuses on aggressively managing high blood pressure in cancer patients to reduce the risk of cardiotoxicity (heart damage) caused by cancer treatments. This approach is particularly important as hypertension (high blood pressure) is a common side effect of many cancer therapies and can exacerbate heart-related issues.
6891112Eligibility Criteria
This trial is for women diagnosed with breast cancer (stages I-IV) who are about to undergo treatment that could harm the heart and have high blood pressure (≥130 mm Hg). They must be able to follow the study's rules, use a Bluetooth-enabled mobile device, and if participating in exercise testing, complete a baseline test without certain heart risks. Excluded are those with severe kidney issues, measurement difficulties due to arm size or lymphedema, recent serious heart problems or stroke.Inclusion Criteria
Your blood pressure is higher than 130 mm Hg.
Willing and able to comply with the requirements of the protocol.
Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device
+5 more
Exclusion Criteria
I cannot have my blood pressure measured accurately on either arm.
Your arm is too big for the blood pressure cuff to get an accurate reading.
I have had recent serious heart problems or a stroke.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either standard or intensive antihypertensive treatment, with medication titration every 4 weeks for the first 3 months, then every 3 months for a total of 12 months
12 months
Visits every 4 weeks for the first 3 months, then every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The PROTECT trial is examining whether intensively treating high blood pressure during breast cancer therapy can better lower blood pressure and reduce heart damage risk compared to standard treatment. It's not testing specific drugs but rather strategies for setting systolic blood pressure goals.
2Treatment groups
Experimental Treatment
Group I: standard-of-care antihypertensive medicationsExperimental Treatment6 Interventions
SBP control will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.
Group II: higher dose antihypertensive medicationsExperimental Treatment6 Interventions
Patients randomized to intensive SBP control will be treated to achieve an SBP goal \<120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal \<140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, NY
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Guest Editorial Challenges in Resistant Hypertension. [2023]Hypertension is the major risk factor for disease and premature death. Although the efficacy of antihypertensive therapy is undisputed, few patients reach target blood pressure. Steps to improve treatment and control include assessment of global cardiovascular risk for the individual patient, improving caregiver support, education and organisation, increasing treatment persistence, using out of office blood pressure monitoring more often, detecting secondary hypertension forms, and referring patients with remaining uncontrolled hypertension to a specialist hypertension centre. In conclusion, there is room for improvement of blood pressure control in hypertensive patients. The clinical benefit of improved blood pressure control may be considerable. This may be particularly true for patients with resistant hypertension.
Olmesartan medoxomil plus hydrochlorothiazide for treating hypertension. [2015]Although achieving blood pressure (BP) control is critical to improve cardiovascular prognosis in hypertensive patients, many of them fail to attain the targets. Most patients with hypertension need more than one antihypertensive agent to achieve the goals. Combination therapy is required when monotherapy fails to attain BP objectives (
Blood Pressure Control in a Diverse Population of Hypertensive Patients With Heart Failure. [2023]Hypertensive patients with heart failure (HF), with reduced or preserved ejection fraction, belong to a vulnerable subset with high mortality risks. In HF patients, the current clinical guideline recommends attaining a systolic blood pressure (BP)
[Goal blood pressure values from the nephrologic viewpoint]. [2007]In order to achieve optimal blood pressure control a combination drug therapy is necessary in the majority of hypertensive patients. Preferred treatment strategies comprise fixed combination drugs which enhance patients' compliance. Low dosages of each substance minimize side effects. The choice of antihypertensive drugs depends on concomitant diseases. The current blood pressure goals are 135/80 mm Hg for patients with essential hypertension and 120/70 mm Hg for patients with diabetes mellitus or renal diseases. In patients with primary renal disease or renal involvement in systemic diseases, ACE inhibitors or angiotensin II blockers with or without diuretics are preferably used.
Association of blood pressure at hospital discharge with mortality in patients diagnosed with heart failure. [2010]Higher blood pressure in acute heart failure has been associated with improved survival; however, the relationship between blood pressure and survival in stabilized patients at hospital discharge has not been established.
Hypertensive Cardiotoxicity in Cancer Treatment-Systematic Analysis of Adjunct, Conventional Chemotherapy, and Novel Therapies-Epidemiology, Incidence, and Pathophysiology. [2020]Cardiotoxicity is the umbrella term for cardiovascular side effects of cancer therapies. The most widely recognized phenotype is left ventricular dysfunction, but cardiotoxicity can manifest as arrhythmogenic, vascular, myocarditic and hypertensive toxicities. Hypertension has long been regarded as one of the most prevalent and modifiable cardiovascular risk factors in the general population, but its relevance during the cancer treatment journey may be underestimated. Hypertensive cardiotoxicity occurs de novo in a substantial proportion of treated cancer patients. The pathology is incompletely characterized-natriuresis and renin angiotensin system interactions play a role particularly in conventional treatments, but in novel therapies endothelial dysfunction and the interaction between the cancer and cardiac kinome are implicated. There exists a treatment paradox in that a significant hypertensive response not only mandates anti-hypertensive treatment, but in fact, in certain cancer treatment scenarios, hypertension is a predictor of cancer treatment efficacy and response. In this comprehensive review of over 80,000 patients, we explored the epidemiology, incidence, and mechanistic pathophysiology of hypertensive cardiotoxicity in adjunct, conventional chemotherapy, and novel cancer treatments. Conventional chemotherapy, adjunct treatments, and novel targeted therapies collectively caused new onset hypertension in 33-68% of treated patients. The incidence of hypertensive cardiotoxicity across twenty common novel therapies for any grade hypertension ranged from 4% (imatinib) to 68% (lenvatinib), and high grade 3 or 4 hypertension in
Hypertension in Cancer Patients and Survivors: Epidemiology, Diagnosis, and Management. [2023]Cancer patients and survivors of cancer have a greater burden of cardiovascular disease compared to the general population. Much of the elevated cardiovascular risk in these individuals is likely attributable to hypertension, as individuals with cancer have a particularly high incidence of hypertension following cancer diagnosis. Treatment with chemotherapy is an independent risk factor for hypertension due to direct effects of many agents on endothelial function, sympathetic activity, and renin-angiotensin system activity as well as nephrotoxicity. Diagnosis and management of hypertension in cancer patients requires accurate blood pressure measurement and consideration of potential confounding factors, such as adjuvant treatments and acute pain, that can temporarily elevate blood pressure readings. Home blood pressure monitoring can be a useful tool to facilitate longitudinal blood pressure monitoring for titration of antihypertensive medications. Selection of antihypertensive agents in cancer patients should account for treatment-specific morbidities and target organ injury.
Etiology and management of hypertension in patients with cancer. [2021]The pathophysiology of hypertension and cancer are intertwined. Hypertension has been associated with an increased likelihood of developing certain cancers and with higher cancer-related mortality. Moreover, various anticancer therapies have been reported to cause new elevated blood pressure or worsening of previously well-controlled hypertension. Hypertension is a well-established risk factor for the development of cardiovascular disease, which is rapidly emerging as one of the leading causes of death and disability in patients with cancer. In this review, we discuss the relationship between hypertension and cancer and the role that hypertension plays in exacerbating the risk for anthracycline- and trastuzumab-induced cardiomyopathy. We then review the common cancer therapies that have been associated with the development of hypertension, including VEGF inhibitors, small molecule tyrosine kinase inhibitors, proteasome inhibitors, alkylating agents, glucocorticoids, and immunosuppressive agents. When available, we present strategies for blood pressure management for each drug class. Finally, we discuss blood pressure goals for patients with cancer and strategies for assessment and management. It is of utmost importance to maintain optimal blood pressure control in the oncologic patient to reduce the risk of chemotherapy-induced cardiotoxicity and to decrease the risk of long-term cardiovascular disease.
Role of Arterial Hypertension and Hypertension-Mediated Organ Damage in Cardiotoxicity of Anticancer Therapies. [2023]Arterial hypertension (AH) is the most common cardiovascular (CV) risk factor in the community and in oncologic patients. It also represents the most important CV condition predisposing to anticancer treatment-related cardiotoxicity. This risk is heightened in the presence of cardiac AH-mediated organ damage (HMOD). Influence of AH and HMOD on the development of cardiotoxicity will be reviewed, with a focus on specific scenarios and implications for management of oncologic patients.
[Hypertension and cancer : Dangerous Liaisons]. [2022]Hypertension is a very common comorbidity in patients suffering from cancer, due to common risk factors. In addition, many oncology drugs, including the new tyrosine kinase-targeting drugs, may induce hypertension or unbalance a pre-existing hypertension. Severe hypertension may lead to cardiac, renal or vascular complications and require the discontinuation or modification of anticancer treatment. It is therefore necessary to be aware of the molecules at risk. The management of hypertension in cancer is the subject of expert consensus and is based on the usual antihypertensive drugs. Adequate cardiac monitoring should be organised before, during and after treatment to allow early management and avoid possible complications. The aim is to provide optimal oncological treatment and improve short-term survival, but also to reduce the long-term cardiovascular risk of cancer survivors.
Hypertension in cancer patients seeking acute care: an opportunity to intervene. [2019]The objectives were to describe clinical factors associated with hypertension or increased blood pressure in cancer patients seeking acute care, to describe the outcomes of these patients related to hypertension or increased blood pressure, and to determine whether these patients receive appropriate treatment and follow-up instructions.
[Improvement of cancer therapy by angiotensin II-induced hypertension chemotherapy]. [2013]Angiotensin II-induced hypertension chemotherapy using cis-diamminedichloroplatinum (II) (DDP) or carboquone (CQ), and a modification of the therapy through combination with a cardiotonic, such as aminophylline (AP) and trans-pi-oxocamphor (pi OC), were compared with regard to therapeutic efficacy on an established mouse mammary carcinoma grown s.c. in syngeneic mice. The hypertension chemotherapy proved to be more effective than conventional administration with the anticancer drug alone. On the other hand, a remarkable improvement in antitumor effect without any increase in the general toxicity was more apparent in the modified hypertension chemotherapy than in angiotensin II hypertension chemotherapy. The combination therapy using DDP, AP or pi OC, but not AT-II, did not produce any increase in antitumor effect as compared to conventional administration with anticancer drug alone. The cytotoxicity of DDP against cultured HeLa cells was not enhanced by co-administration with AT-II, AP and/or pi OC. Thus, the increase in the therapeutic efficacy obtained by the modified hypertension chemotherapy may be attributable to the specific augmentation in delivery of the anticancer drug to the tumor tissue, but not to any specific enhancement in the cytotoxicity of the anticancer drug against to the tumor cells.