Reversal of an Unfavorable Effect of Hydrochlorothiazide Compared to Angiotensin Converting Enzyme Inhibitor on Serum Uric Acid and Oxypurines Levels by Estrogen-progestin Therapy in Hypertensive Postmenopausal Women.
1 other identifier
interventional
180
0 countries
N/A
Brief Summary
The aim was to assess the effect of estrogen-progestin therapy (EPT) on serum levels of uric acid (SUA) and its precursors: xanthine (X) and hypoxanthine (HX) and on uric acid (UA) renal excretion in hypertensive postmenopausal women treated with an angiotensin-converting enzyme inhibitor (ACEI) or thiazide diuretic (HCTZ).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jan 2000
Longer than P75 for phase_4 hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2005
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedApril 22, 2019
April 1, 2019
1.2 years
April 12, 2019
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure in mmHg
As compared with normotensive women, hypertensive women showed higher office and ambulatory blood pressure, as well as a lower night-time decrease in systolic and diastolic blood pressure. Both perindopril and hydrochlorothiazide led to a similar reduction in arterial blood pressure in hypertensive women. After 12 months of treatment, statistically significant differences were observed between the EPT+ and EPT- subgroups in systolic and diastolic office-based blood pressure in the study group treated with ACEI. Such effect of EPT on ABPM(ambulatory blood pressure monitoring) was not observed in all study participants. Multiple linear regression models have shown that after 12 months of antihypertensive treatment there were no significant differences in night-time decrease in blood pressure caused by EPT treatment, despite its significant change when compared to baseline values for ACEI and HCTZ subgroups.
12 months
Secondary Outcomes (1)
Renal plasma flow in ml/min
12 months
Other Outcomes (2)
Serum uric acid levels in mg/dl
12 months
Serum xanthine and hypoxanthine levels in mg/dl
12 months
Study Arms (6)
Control Group
NO INTERVENTIONControl group consisted of 40 postmenopausal women with normal blood pressure.
Hypertensive women group receiving hydrochlorothiazide
EXPERIMENTALPatients received hydrochlorothiazide 25 mg/day p.o. for 1 year.
Hypertensive women group receiving perindopril.
EXPERIMENTALPatients received perindopril 4 mg/day p.o for 1 year.
Hypertensive women group receiving hydrochlorothiazide and EPT
EXPERIMENTALPatients received hydrochlorothiazide 25 mg/day p.o. and estrogen-progestin therapy- transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 1 year
Hypertensive women group receiving perindopril and EPT.
EXPERIMENTALPatients received perindopril 4 mg/day p.o and estrogen-progestin therapy- transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 1 year
Hipotensive women group receiving EPT.
EXPERIMENTALPatients received estrogen-progestin therapy- transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 1 year.
Interventions
4 mg/day p.o. for 12 months
hydrochlorothiazide 25 mg/day p.o. for 12 months
Transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 12 months
Eligibility Criteria
You may qualify if:
- Treatment-naive postmenopausal women
- Diagnosed hypertension (grade 1 or 2 according to ESH/ESC 2013 guidelines)
You may not qualify if:
- breast cancer in a first-degree relative
- hyperplasia diagnosed by endometrial biopsy,
- history of thromboembolic diseases,
- current or history of use of estrogen-progestin therapy or contraceptives
- diabetes,
- kidney failure,
- thyroid disease,
- heart and other chronic diseases (secondary hypertension, atrial fibrillation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Posadzy-Malaczynska A, Rajpold K, Woznicka-Leskiewicz L, Marcinkowska J. Reversal of an unfavorable effect of hydrochlorothiazide compared to angiotensin converting enzyme inhibitor on serum uric acid and oxypurine levels by estrogen-progestin therapy in hypertensive postmenopausal women. Curr Med Res Opin. 2019 Oct;35(10):1687-1697. doi: 10.1080/03007995.2019.1612656. Epub 2019 Jun 17.
PMID: 31033362DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Habilitated doctor of Medical Sciences in Medicine
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 19, 2019
Study Start
January 10, 2000
Primary Completion
March 6, 2001
Study Completion
November 17, 2005
Last Updated
April 22, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share