Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00898170
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.


Condition Intervention
Myoma
Hypertension
Procedure: myoma removal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • 24 hour holter monitoring of blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • erythropoetin level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: myoma, with or without hypertension
those with myoma with or without hypertension in holter monitoring
Procedure: myoma removal
surgical removal of myoma by hysterectomy

Detailed Description:

Background:

Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. Early reports suggested the association of myoma and hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis.

Patients & Methods:

In this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

  Eligibility

Ages Eligible for Study:   22 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • candidate for myoma removal by hysterectomy
  • operable
  • hysterectomy is indicated

Exclusion Criteria:

  • patient refusal
  • inoperable patients
  • other secondary cases of hypertension
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00898170

Locations
Iran, Islamic Republic of
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 51318
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: javad kojuri, M.D. Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: javad Kojuri, shiraz university of medical sciences
ClinicalTrials.gov Identifier: NCT00898170     History of Changes
Other Study ID Numbers: 88-2505
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
myoma
hypertension
erythropoetin
blood pressure
erythropoetin level

Additional relevant MeSH terms:
Hypertension
Myoma
Cardiovascular Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014