Mechanisms of Anti-VEGF Induced Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02156310
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Information provided by (Responsible Party):
Arduino Mangoni, Flinders University

Brief Summary:

Background: High blood pressure is a common complication observed in cancer patients prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and strokes, thus adversely affecting survival and quality of life in this patient group. However, little is known about the mechanisms leading to high blood pressure with anti-VEGF drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e. antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic management and reduce the risk associated with hypertension and proteinuria in patients with cancer.

Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib, i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure changes over time after commencing anti-VEGF treatment; 2) identify whether there are any relationships between pre-study and baseline blood pressure values, treatment with specific antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment; and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed either before or after commencing anti-VEGF treatment, lead to a better blood pressure control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses will be conducted to assess and identify associations and will account for other patient's characteristics and repeated observations over time. The investigators plan to conduct this study over 6 months.

Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time, inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug, sunitimib, will allow initial comparisons across different groups.

The results deriving from this study will provide important knowledge on 1) patterns of blood pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs or drug classes might be better than others in preventing and managing anti-VEGF induced hypertension and proteinuria.

Condition or disease
Renal Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2000 participants
Time Perspective: Retrospective
Official Title: Associations Between Antihypertensive Drugs and Patterns of Blood Pressure Changes: a Strategy to Reduce the Burden of Anti-VEGF Induced Hypertension
Study Start Date : January 2009
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Number of patients developing proteinuria with anti-VEGF drugs [ Time Frame: 6 months ]
  2. Survival of renal cancer patients on anti-VEGF drugs [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with renal cancer randomised to active treatment, active comparator or placebo in two finished randomised controlled trials

Inclusion Criteria:

  • Renal Cancer

Exclusion Criteria:

  • Other terminal illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02156310

Australia, South Australia
Department of Clinical Pharmacology
Adelaide, South Australia, Australia, 5042
Sponsors and Collaborators
Arduino Mangoni
Principal Investigator: Arduino A Mangoni, MD, PhD Flinders University

Responsible Party: Arduino Mangoni, Professor of Clinical Pharmacology, Flinders University Identifier: NCT02156310     History of Changes
Other Study ID Numbers: AAMFUSA001
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Vascular Diseases
Cardiovascular Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents