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The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endothelial Dysfunction

Intervention: Tekturna (Aliskiren) (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Amir Lerman, MD, Principal Investigator, Affiliation: Mayo Clinic

Summary

We will study the hypothesis that long-term Tekturna treatment will improve endothelial function and the production and function of endothelial progenitor cells (EPCs) in patients with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the function of circulating endothelial progenitor cells, compared to placebo, in association with a reduction in inflammation and oxidative stress.

Clinical Details

Official title: The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Endothelial function via EndoPAT and endothelial progenitor cells

Secondary outcome: The effect of Tekturna on subjects with Endothelial dysfunction based on EndoPAT scores

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Age > 18 years old

2. More than two of the following cardiovascular risk factors (determined by prescreen phone call): family history of cardiovascular disease, physical inactivity/sedentary lifestyle, obesity or overweight, family history of diabetes mellitus or hypertension, total cholesterol > 200 mg/dL, LDL > 130 mg/dL, HDL < 50 mg/dL, smoking, stress, or Triglycerides > 150 mg/dL

3. Demonstrated endothelial dysfunction (reactive hyperemia - EndoPAT score < 2. 0) at

time of screening

Exclusion Criteria:

1. Serum potassium > 5. 0 mmol/L documented at any time prior to the study

2. History of any cardiovascular event (stroke, TIA, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to the study

3. Hypertension or hypotension (at Randomization): any patient with msSBP ≥ 170 mmHg, msSBP < 100 mmHg or msDBP ≥ 110 mmHg

4. Congestive heart failure NYHA class III and IV

5. Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e. g. ACEI, ARB or aldosterone-antagonist

6. Unstable serum creatinine

7. Second (II) or third (III) degree heart block without a pacemaker

8. Concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia

9. Clinically significant valvular heart disease

10. Known renal artery stenosis

11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:

- History of major gastrointestinal tract surgery such as gastrectomy,

gastroenterostomy, or bowel resection

- Any history of pancreatic injury, pancreatitis or evidence of impaired

pancreatic function/injury as indicated by abnormal lipase or amylase

- Evidence of hepatic disease as determined by a history of hepatic

encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt

12. History of malignancy other than basal cell skin cancer within the past five years

13. Any concurrent life threatening condition with a life expectancy less than 2 years

14. History or evidence of drug or alcohol abuse within the last 12 months

15. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study

16. History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs

17. History of noncompliance to medical regimens or unwillingness to comply with the study protocol

18. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer

19. Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety

20. Persons directly involved in the execution of this protocol

21. Pregnant or nursing (lactating) women

22. Women of Child-Bearing Potential (WOCBP) unless postmenopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities

Locations and Contacts

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Amir Lerman, M.D., Phone: 507-255-4152, Email: lerman.amir@mayo.edu
Additional Information

Starting date: February 2010
Last updated: April 12, 2011

Page last updated: December 08, 2011

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