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Intensive Blood Pressure Control for Cardiotoxicity in Cancer Patients

Phase 2

Recruiting

Led By Anthony Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned treatment with cardiotoxic cancer therapy (e.g., anthracycline chemotherapy, with or without HER2-targeted therapy)

Biopsy proven breast cancer (stage I-IV)

Must not have

Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema)

Cardiac comorbidity, including any of the following: Acute coronary syndrome within 3 months prior to randomization, symptomatic heart failure (NYHA class III/IV) within past 6 months, history of stroke, cardiac transplantation, other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find if intensively lowering blood pressure safely helps cancer patients reduce risk of heart issues.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this study isn't testing specific medications, potential side effects may include typical reactions related to antihypertensive drugs such as dizziness, fatigue, headaches or more rarely severe drops in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for cancer treatment that may affect my heart.

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My breast cancer diagnosis was confirmed through a biopsy.

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I was assigned female at birth.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have my blood pressure measured accurately on either arm.

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I have had recent serious heart problems or a stroke.

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I do not have any major heart, lung, or other health issues that would make exercise testing unsafe for me.

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

mean change in systolic blood pressure (SBP) from baseline to 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiogram

2016

Completed Phase 2

~1910

Blood pressure measurement

2019

N/A

~360