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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09519 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-007083 | Other Identifier | Mayo Clinic Institutional Review Board |
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This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.
PRIMARY OBJECTIVES:
I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.
II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.
III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.
OUTLINE: This is an observational study.
Patients attend hypertension clinic visits, undergo optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients attend hypertension clinic visits, undergo optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiovascular events (MACE) | 1-year MACE rates between patients with B-cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies will be compared with patients who do not develop HTN on BTKi. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new and/or worsening hypertension (HTN) | Incidence of new or worsening HTN over 1 year of BTKi therapy will be recorded (defined as blood pressure (BP) increase to>140 mmHg systolic or > 90 mmHg diastolic). | Up to 12 months |
| Hemodynamic changes associated with new and/or worsening HTN |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joerg Herrmann, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Impedance cardiography (ICG) changes from before to after BTKi initiation and anti-HTN therapy implication will be recorded to assess hemodynamic changes. |
| Up to 12 months |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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