Influence of Nebivolol on Postmenopausal Women

NCT01161823 | Unknown DMC

• 2 other identifiers: 451/20092009-011527-31
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hot Flashes; Heart Rate; Blood Pressure; Endostatin; Sexual Function

Outcome Measures

Primary Outcomes (1)

• Number of hot flashes/palpitations

  Number of hot flashes/palpitations during month one and month three compared between nebivolol and phytoestrogens

  3 Months, 4 appointments

Secondary Outcomes (4)

• Hemodynamic changes

  3 Months, 4 appointments

• Sexual function

  before and after 3 months of treatment

• Endostatin

  Baseline and after 3 months

• Quality of life

  baseline and after 3 months

Study Arms (2)

Nebivolol

2,5mg or maximum 5mg per day

Menoflavon

2 times 1 pill at 40mg Isoflavone per day

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 Postmenopausal women

You may qualify if:

• Menopausal patients (estrogen \<20 pg/ml and FSH \>35 mIU/ml)
• The patients are sexually active
• The patients have hot flushes
• The patients have palpitations or extrasystoles

You may not qualify if:

• Contraindications for a beta-blocker therapy such as:
• Patients with COPD
• Patients with an AV-block
• Patients with a bradycardia (meaning a heart rate \<50 beats per minute)
• Patients with hypotension (RR \<100/80 mmHg)
• Patients with a PAD (stage III, IV)
• Patients with Asthma
• Patients with Morbus Raynaud
• Patients with a carcinoma
• Patients, who have already been treated because of hypertension
• Patients, who receive hormone replacement therapy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Cardiology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanette Strametz-Juranek, MD

  MUV, Department of Internal Medicine II, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: July 14, 2010
• Study Start: January 1, 2010
• Last Updated: January 12, 2016

Record last verified: 2010-04

Locations

AU (1)