Effect of Myoma Removal on Blood Pressure and Erythropoetin Level - Full Text View

Sponsored by:	Shiraz University of Medical Sciences
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00898170

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:	Diagnostic, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment
Official Title:	Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

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
myoma, with or without hypertension: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898170

Locations

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

Keywords provided by Shiraz University of Medical Sciences:

myoma
hypertension
erythropoetin
blood pressure
erythropoetin level

Study placed in the following topic categories:

Epoetin Alfa
Neoplasms, Connective and Soft Tissue
Hematinics

Vascular Diseases
Myoma
Hypertension

Additional relevant MeSH terms:

Epoetin Alfa
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Hematinics
Hematologic Agents
Vascular Diseases
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Myoma
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009