Influence of Nebivolol on Postmenopausal Women
Recruitment status was: Recruiting
After menopause the coronary artery disease (CAD) risk increases rapidly to an equivalent risk of men with the same age. The rising incidence of CAD could be a subsequent decline of endogenous estrogen blood levels after the menopause. Estrogen leads to vasodilation and vasoprotection through an increase of Nitric Oxide (NO). NO deficiency results in endothelial stiffness and dysfunction with a subsequent initiation of atherosclerosis. Menopausal status is associated with an increase of the sympathetic nerve activity leading to hypertension, increased heart rate and palpitations. Recent studies show an importance of vasoactive substances (e.g. NO) in the physiology of hot flashes. Thus, hot flashes may be associated with a decreased NO production and release. Additionally, it is well known that during and after menopause women experience a change in sexual function (declined libido and increased dyspareunia) due to decreasing estrogen blood levels. Recently, a new angiostatic parameter - Endostatin (ENST) - has been shown to be involved in EC function. There is also evidence that ENST levels increase during NO stimulation. Nebivolol, a ß-blocker of the third generation, has been shown to release NO to a significant amount in the EC. It is safe and effective in reducing blood pressure to the target level. However, there is no data of the effect of Nebivolol on sexual function, on clinical symptoms (palpitations, increased heart rate and hot flashes) and ENST in postmenopausal women. The present study investigates the effect of a NO-releasing ß-blocker compared to a phytoestrogen therapy considering clinical signs of menopause such as palpitations, hot flashes and sexual functioning in postmenopausal women. Therefore, the use of a ß-blocker treatment is warranted. Further, this study tries to elucidate the role of NO release in postmenopausal symptoms and may gain new insights in the pathophysiology of hot flashes and increased sympathetic nerve activity. Thus, this trial should explore an advantage of Nebivolol therapy in contrast to a phytoestrogen therapy.
Null hypothesis: Climacteric disorders as measured by the MRS-II in patients with a Nebivolol therapy is not lower than in patients with phytoestrogen therapy. Alternative hypothesis: Climacteric disorders in patients as measured by the MRS-II with a Nebivolol therapy is lower than in patients with phytoestrogen therapy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Nebivolol on Climacteric Disorders in Postmenopausal Women. A Randomized, Open Label Trial|
- Number of hot flashes/palpitations [ Time Frame: 3 Months, 4 appointments ] [ Designated as safety issue: No ]Number of hot flashes/palpitations during month one and month three compared between nebivolol and phytoestrogens
- Hemodynamic changes [ Time Frame: 3 Months, 4 appointments ] [ Designated as safety issue: No ]Measurement of blood pressure and heart rate at baseline and every four weeks.
- Sexual function [ Time Frame: before and after 3 months of treatment ] [ Designated as safety issue: No ]Sexual function will be investigated by the Female Sexual Function Index (FSFI-D)
- Endostatin [ Time Frame: Baseline and after 3 months ] [ Designated as safety issue: No ]Blood sample of Endostatin will be drawn before and after 3 months of treatment. Endostatin, a cleavage product of collagen XVIII, inhibits angiogenesis. By decreasing neovascualtrization of atherosclerotic plaques, Endostatin might be able to stop the progression of atherosclerosis.
- Quality of life [ Time Frame: baseline and after 3 months ] [ Designated as safety issue: No ]Menopause Rating Scale II (MRS II) is a self-assessment scale to quantify menopausal symptoms includes 11 questions to evaluate the "quality of life" in our cohorts.
|Study Start Date:||January 2010|
2,5mg or maximum 5mg per day
2 times 1 pill at 40mg Isoflavone per day
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01161823
|Department of Cardiology, Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Jeanette Strametz-Juranek, MD||MUV, Department of Internal Medicine II, Division of Cardiology|