A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
研究概览
简要总结
RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.
PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.
SECONDARY OBJECTIVES:
I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed solid tumor malignancy AND hypertension, defined as a systolic pressure > 130 OR a diastolic pressure > 80
- •Patients cannot be on active chemotherapy or radiation therapy; start of treatment with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy or radiation therapy
- •Creatinine < 2.5
- •Potassium < ULN
- •Ability to understand and the willingness to sign a written informed consent document
- •HIV positive patients are eligible to participate in this study
排除标准
- •Patients who are pregnant or nursing due to significant risk to the fetus/infant
- •Patients who are unable to take oral medications
- •Patients who are currently taking an ACE-Inhibitor or ARB
研究组 & 干预措施
Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
干预措施: benazepril hydrochloride (Drug)
Arm II
Patients receive oral lisinopril once daily on days 1-7.
干预措施: lisinopril (Drug)
Arm II
Patients receive oral lisinopril once daily on days 1-7.
干预措施: laboratory biomarker analysis (Other)
Arm III
Patients receive oral ramipril twice daily on days 1-7.
干预措施: laboratory biomarker analysis (Other)
Arm III
Patients receive oral ramipril twice daily on days 1-7.
干预措施: ramipril (Drug)
Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
干预措施: losartan potassium (Drug)
Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
时间窗: 7 days post-baseline
次要结局
- Change in Ang II, VEGF, PlGF, and ACE Levels(1 week)