Influence of Nebivolol on Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01161823
First received: April 16, 2010
Last updated: July 13, 2010
Last verified: April 2010
  Purpose

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.


Condition
Hot Flashes
Heart Rate
Blood Pressure
Endostatin
Sexual Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Nebivolol on Climacteric Disorders in Postmenopausal Women. A Randomized, Open Label Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2010
Groups/Cohorts
Nebivolol
2,5mg or maximum 5mg per day
Menoflavon
2 times 1 pill at 40mg Isoflavone per day

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

60 Postmenopausal women

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161823

Locations
Austria
Department of Cardiology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Jeanette Strametz-Juranek, MD    0043140400 ext 4618    jeanette.strametz-juranek@meduniwien.ac.at   
Principal Investigator: Jeanette Strametz-Juranek, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Jeanette Strametz-Juranek, MD MUV, Department of Internal Medicine II, Division of Cardiology
  More Information

No publications provided

Responsible Party: Department of Cardiology
ClinicalTrials.gov Identifier: NCT01161823     History of Changes
Other Study ID Numbers: 451/2009, 2009-011527-31
Study First Received: April 16, 2010
Last Updated: July 13, 2010
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014