Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Study Classification
OBSERVATIONAL
Study Start Date
1987-09-30
Study Completion Date
1992-07-31
Brief Summary
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To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal and hypertensive pregnancy.
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Detailed Description
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BACKGROUND:
The renin-angiotensin system is involved in the physiology of pregnancy in two ways. Circulating angiotensin II affects blood pressure, renal hemodynamics, and uteroplacental blood flow. Abnormalities in angiotensin II production rates in hypertensive pregnancy contribute to the hemodynamic changes seen in the disease. Additionally, there is a form of the renin-angiotensin system in kidney, ovary, and placenta whose function is regulated by prorenin. Prorenin, activated by a specific receptor, is involved in the regulation of steroid hormone biosynthesis and renal and uteroplacental blood flow.
The study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The study was longitudinal in design. Measurements were made of glomerular filtration rate, renal plasma flow or uterine blood flow. To define first trimester changes, studies were conducted on in vitro fertilization and ovarian failure patients who had a broad spectrum of plasma prorenins. Since interrelated changes in renin and prostaglandins may participate in the pathogenesis of hypertensive pregnancy, RAAS, prostaglandins, and uteroplacental flow velocity profiles were monitored during a placebo-controlled trial of low-dose aspirin in chronic hypertensives.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
The renin-angiotensin system is involved in the physiology of pregnancy in two ways. Circulating angiotensin II affects blood pressure, renal hemodynamics, and uteroplacental blood flow. Abnormalities in angiotensin II production rates in hypertensive pregnancy contribute to the hemodynamic changes seen in the disease. Additionally, there is a form of the renin-angiotensin system in kidney, ovary, and placenta whose function is regulated by prorenin. Prorenin, activated by a specific receptor, is involved in the regulation of steroid hormone biosynthesis and renal and uteroplacental blood flow.
The study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The study was longitudinal in design. Measurements were made of glomerular filtration rate, renal plasma flow or uterine blood flow. To define first trimester changes, studies were conducted on in vitro fertilization and ovarian failure patients who had a broad spectrum of plasma prorenins. Since interrelated changes in renin and prostaglandins may participate in the pathogenesis of hypertensive pregnancy, RAAS, prostaglandins, and uteroplacental flow velocity profiles were monitored during a placebo-controlled trial of low-dose aspirin in chronic hypertensives.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Conditions
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Cardiovascular Diseases
Heart Diseases
Hypertension
Pregnancy Toxemias
Pre-Eclampsia
Eligibility Criteria
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Inclusion Criteria
No eligibility criteria
Maximum Eligible Age
100 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
lead
References
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Thaler I, Weiner Z, Itskovitz J. Systolic or diastolic notch in uterine artery blood flow velocity waveforms in hypertensive pregnant patients: relationship to outcome. Obstet Gynecol. 1992 Aug;80(2):277-82.
Reference Type
BACKGROUND
Pitarresi TM, Rubattu S, Heinrikson R, Sealey JE. Reversible cryoactivation of recombinant human prorenin. J Biol Chem. 1992 Jun 15;267(17):11753-9.
Reference Type
BACKGROUND
Rubattu S, Quimby FW, Sealey JE. Tissue renin and prorenin increase in female cats during the reproductive cycle without commensurate changes in plasma, amniotic or ovarian follicular fluid. J Hypertens. 1991 Jun;9(6):525-35. doi: 10.1097/00004872-199106000-00008.
Reference Type
BACKGROUND
Sealey JE, von Lutterotti N, Rubattu S, Campbell WG Jr, Gahnem F, Halimi JM, Laragh JH. The greater renin system. Its prorenin-directed vasodilator limb. Relevance to diabetes mellitus, pregnancy, and hypertension. Am J Hypertens. 1991 Dec;4(12 Pt 1):972-7. doi: 10.1093/ajh/4.12.972.
Reference Type
BACKGROUND
Lenz T, James GD, Laragh JH, Sealey JE. Prorenin secretion from human placenta perfused in vitro. Am J Physiol. 1991 Jun;260(6 Pt 1):E876-82. doi: 10.1152/ajpendo.1991.260.6.E876.
Reference Type
BACKGROUND
Itskovitz J, Rubattu S, Rosenwaks Z, Liu HC, Sealey JE. Relationship of follicular fluid prorenin to oocyte maturation, steroid levels, and outcome of in vitro fertilization. J Clin Endocrinol Metab. 1991 Jan;72(1):165-71. doi: 10.1210/jcem-72-1-165.
Reference Type
BACKGROUND
Thaler I, Manor D, Rottem S, Timor-Tritsch IE, Brandes JM, Itskovitz J. Hemodynamic evaluation of the female pelvic vessels using a high-frequency transvaginal image-directed Doppler system. J Clin Ultrasound. 1990 May;18(4):364-9. doi: 10.1002/jcu.1870180423.
Reference Type
BACKGROUND
August P, Lenz T, Ales KL, Druzin ML, Edersheim TG, Hutson JM, Muller FB, Laragh JH, Sealey JE. Longitudinal study of the renin-angiotensin-aldosterone system in hypertensive pregnant women: deviations related to the development of superimposed preeclampsia. Am J Obstet Gynecol. 1990 Nov;163(5 Pt 1):1612-21. doi: 10.1016/0002-9378(90)90639-o.
Reference Type
BACKGROUND
Thaler I, Manor D, Brandes J, Rottem S, Itskovitz J. Basic principles and clinical applications of the transvaginal Doppler duplex system in reproductive medicine. J In Vitro Fert Embryo Transf. 1990 Apr;7(2):74-85. doi: 10.1007/BF01135578. No abstract available.
Reference Type
BACKGROUND
Thaler I, Manor D, Itskovitz J, Rottem S, Levit N, Timor-Tritsch I, Brandes JM. Changes in uterine blood flow during human pregnancy. Am J Obstet Gynecol. 1990 Jan;162(1):121-5. doi: 10.1016/0002-9378(90)90834-t.
Reference Type
BACKGROUND
Lenz T, Sealey JE, Maack T, James GD, Heinrikson RL, Marion D, Laragh JH. Half-life, hemodynamic, renal, and hormonal effects of prorenin in cynomolgus monkeys. Am J Physiol. 1991 Apr;260(4 Pt 2):R804-10. doi: 10.1152/ajpregu.1991.260.4.R804.
Reference Type
BACKGROUND
August P, Mueller FB, Sealey JE, Edersheim TG. Role of renin-angiotensin system in blood pressure regulation in pregnancy. Lancet. 1995 Apr 8;345(8954):896-7. doi: 10.1016/s0140-6736(95)90012-8.
Reference Type
BACKGROUND
Sealey JE, Itskovitz-Eldor J, Rubattu S, James GD, August P, Thaler I, Levron J, Laragh JH. Estradiol- and progesterone-related increases in the renin-aldosterone system: studies during ovarian stimulation and early pregnancy. J Clin Endocrinol Metab. 1994 Jul;79(1):258-64. doi: 10.1210/jcem.79.1.8027239.
Reference Type
BACKGROUND
Weiner Z, Thaler I, Levron J, Lewit N, Itskovitz-Eldor J. Assessment of ovarian and uterine blood flow by transvaginal color Doppler in ovarian-stimulated women: correlation with the number of follicles and steroid hormone levels. Fertil Steril. 1993 Apr;59(4):743-9. doi: 10.1016/s0015-0282(16)55853-1.
Reference Type
BACKGROUND
Lenz T, Sealey JE, August P, James GD, Laragh JH. Tissue levels of active and total renin, angiotensinogen, human chorionic gonadotropin, estradiol, and progesterone in human placentas from different methods of delivery. J Clin Endocrinol Metab. 1989 Jul;69(1):31-7. doi: 10.1210/jcem-69-1-31.
Reference Type
BACKGROUND
Itskovitz J, Bruneval P, Soubrier F, Thaler I, Corvol P, Sealey JE. Localization of renin gene expression to monkey ovarian theca cells by in situ hybridization. J Clin Endocrinol Metab. 1992 Nov;75(5):1374-80. doi: 10.1210/jcem.75.5.1430100.
Reference Type
BACKGROUND
Gahnem F, Sealey JE, Atlas SA, Laragh JH. Inhibition of human renin by rat plasma. Rat angiotensinogen is a competitive inhibitor of the human renin-substrate interaction. Am J Hypertens. 1992 Aug;5(8):495-501. doi: 10.1093/ajh/5.8.495.
Reference Type
BACKGROUND
Thaler I, Weiner Z, Itskovitz J. Renal artery flow velocity waveforms in normal and hypertensive pregnant women. Am J Hypertens. 1992 Jun;5(6 Pt 1):402-5. doi: 10.1093/ajh/5.6.402.
Reference Type
BACKGROUND
Itskovitz J, Rubattu S, Levron J, Sealey JE. Highest concentrations of prorenin and human chorionic gonadotropin in gestational sacs during early human pregnancy. J Clin Endocrinol Metab. 1992 Sep;75(3):906-10. doi: 10.1210/jcem.75.3.1517384.
Reference Type
BACKGROUND
Other Identifiers
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1086
Identifier Type: -
Identifier Source: org_study_id
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