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Cardiovascular DisorderNCT04467021

Cancer and Blood Pressure Management, CARISMA Study

A study testing Best Practice, Blood Pressure Measurement and Clinical Management in people with Cardiovascular Disorder and Chronic Kidney Disease, run by ECOG-ACRIN Cancer Research Group at 25 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid cancer that has spread to other places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor cancer therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Best Practice, Blood Pressure Measurement and Clinical Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
25 sitesUnited States
Study dates
29 Oct 2020to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English speaking
  • Patient must have histologically or cytologically-proven advanced metastatic renal cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, vandetanib, or axitinib)
  • NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then alternative non-sulfa medications can be considered in consultation with the C-BAC. Patient with a noted severe allergic reactions to medications listed in the algorithms is not necessarily excluded from this trial, as alternative medications could be considered in consultation with the C-BAC. Moreover, the patient treated with pre-existing medications that may interact with proposed BP medications is not necessarily excluded, as alternative medications exist. The clinical significance of any potential drug interactions can also be addressed with the C-BAC.
  • Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with immunotherapy is also permissible
  • Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk as defined by one or more of the following:
  • Clinical CV disease (history of myocardial infarction [MI] acute coronary syndrome, coronary revascularization, carotid endarterectomy or stenting greater than 3 months prior to registration, peripheral artery disease, cerebrovascular accident greater than 3 months prior to registration, abdominal aortic aneurysm or heart failure [HF])
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  • An American College of Cardiology/American Heart Association (ACC/AHA) CV risk score of at least 10%
  • Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR] between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an eGFR < 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
  • Patient must have systolic blood pressure (SBP) >= 130 mmHg on two or more occasions according to any in-clinic visit in the 12 weeks prior to or during their initial 4 weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension or on pre-existing anti-hypertensive medications are eligible for enrollment. However, patient must not be on more than 3 baseline blood pressure medications at time of entry
  • NOTE: If a patient has a single elevated SBP >= 130mmHg but not on repeat assessment, an additional SBP assessment should be performed to confirm ineligibility
  • Patient must agree to comply with performing home blood pressure monitoring using an Omron7250 oscillometric monitor at home, or equivalent models
  • Women of childbearing potential and sexually active males 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
  • Patient must have internet access through a computer, tablet, or smart phone to use EASEE-PRO and home BP monitoring. A valid phone number to receive text messages and email address are also necessary
  • Leukocytes >= 3,000/mcL (obtained within 14 days prior to registration)
  • Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to registration)
  • Platelets >= 100,000/mcL (obtained within 14 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration)
  • Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patient with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patient with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patient with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
  • Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Who cannot join

  • Patient must not have end-stage renal failure on dialysis, history of repeated hyperkalemia with a potassium > 5.5 mEq/l, or have a kidney transplant, or an eGFR < 30 ml/min/1.73 m^2
  • Patient must not have coronary artery bypass grafting, MI acute coronary syndrome severe/unstable angina, stroke, transient ischemic attack, clinically significant bleeding requiring hospitalization or pulmonary embolism within 3 months prior to registration
  • Patient must not have brain surgery or radiotherapy within 2 weeks prior to registration
  • Patient must not have uncontrolled blood pressure defined by SBP > 160 mmHg on three or more antihypertensives prior to TKI initiation
  • Patient with an arm circumference too large (> 50 cm) or small (< 17 cm) to allow accurate BP measurement with available devices will not be eligible
  • 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 14 days prior to registration to rule out pregnancy. 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: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or 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)

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

Other trials in United States

About this study

Official title: Cancer Therapy Risk-Reduction With Intensive Systolic BP Management (CARISMA) - a Phase II Study

This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid cancer that has spread to other places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor cancer therapy. This study is being done to find out if a systolic blood pressure to a target of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors understand the best way to control blood pressure in kidney or thyroid cancer patients taking anti-angiogenic tyrosine kinase inhibitor.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the feasibility of an intensive (systolic blood pressure [SBP] < 120 mmHg) "Intervention" versus standard care (SBP < 140 mmHg) "Non-Intervention" approach to blood pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating anti-angiogenic tyrosine kinase inhibitors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).

ARM B: Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks and upload the recorded blood pressures to a central monitoring team.

Being tested
Best Practice, Blood Pressure Measurement, Clinical Management, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Cardiovascular Diseases, Renal Insufficiency, Chronic, Carcinoma, Renal Cell, Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual blood pressure management

  • Blood Pressure MeasurementOther

    Undergo blood pressure measurement

  • Clinical ManagementOther

    Undergo intensive systolic BP management

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04467021
Study groupRoleWhat they receive
Arm A (intensive systolic blood pressure management)ExperimentalPatients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks, and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).
Receives: Other: Blood Pressure Measurement; Other: Clinical Management; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm B (usual blood pressure management)Active comparatorPatients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks, and upload the recorded blood pressures to a central monitoring team.
Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in systolic blood pressure (SBP) based on automated office BP measurements

    Differences in SBP over the 6- month study period between intensive BP control (intervention) versus standard care (non-intervention group) will be compared using the "difference-indifference" method. All mixed effects models will be estimated using generalized estimating equations (GEE).

    Measured: Up to 6 months

Secondary outcomes (8)

  1. Difference in SBP based on all automated home and office BP measurements

    Based on all automated home and office BP measurements.

    Measured: Up to 6 months

  2. Study retention rates

    Will compare the study retention rates between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation

    Measured: Up to 6 months

  3. Frequency of automated home SBP measurements > 180 mmHg or < 90 mmHg or diastolic (D)BP > 110 mmHg

    The frequency of orthostatic hypotension as defined by > 20 mmHg decreases in office SBP with standing; or symptomatic hypotension, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) criteria, in participants in the intervention and non-intervention group arms.

    Measured: Up to 6 months

  4. Differences in symptoms and health-related quality of life

    Will compare the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue between the intensive SBP versus standardlcCare group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.

    Measured: Up to 6 months

  5. Differences in patient-reported medication compliance

    Will compare the medication compliance between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.

    Measured: Up to 6 months

  6. Patient-rated adverse events associated with hypertension, hypotension and anti-hypertensive medications

    Measured: Up to 6 months

  7. Participant satisfaction with BP care

    The participant satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.

    Measured: Up to 6 months

  8. Provider satisfaction with BP care

    The provider satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start29 Oct 2020
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04467021
Sponsor's protocol ID
EAQ191
Other IDs
NCI-2020-00900, EAQ191, ECOG-ACRIN-EAQ191, EAQ191, UG1CA189828
Status last verified
Sep 2026
First submitted
7 Jul 2020
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ky B, Liu T, Margulies KB, Mitchell JD, Haas NB, Gareen IF, Thangarajah M, Sicks JD, Domenico C, Narayan VK, Smith AM, Wilcox NS, Mittal K, Rhee JW, Armenian SH, Saphner T, Paul AK, Gartrell BA, Zaha VG, Anari F, Wong RL, Townsend RR, Wagner LI. Cluster Randomized Controlled Trial of Intensive Systolic Blood Pressure Control in Patients With Renal Cell or Thyroid Cancer Receiving VEGFR Tyrosine Kinase Inhibitors: ECOG-ACRIN EAQ191. Hypertension. 2026 Jul;83(7):e26016. doi: 10.1161/HYPERTENSIONAHA.125.26016. Epub 2026 May 20.

    PubMed 42158981

  • Narayan V, Liu T, Song Y, Mitchell J, Sicks J, Gareen I, Sun L, Denduluri S, Fisher C, Manikowski J, Wojtowicz M, Vadakara J, Haas N, Margulies KB, Ky B. Early Increases in Blood Pressure and Major Adverse Cardiovascular Events in Patients With Renal Cell Carcinoma and Thyroid Cancer Treated With VEGFR TKIs. J Natl Compr Canc Netw. 2023 Oct;21(10):1039-1049.e10. doi: 10.6004/jnccn.2023.7047.

    PubMed 37856199

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Blood Pressure Measurement and Clinical Management in people with Cardiovascular Disorder and Chronic Kidney Disease, run by ECOG-ACRIN Cancer Research Group at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in systolic blood pressure (SBP) based on automated office BP measurements (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04467021, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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