Renin and Prorenin in Pregnancy

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005207
• Other study ID #: 1086
• Secondary ID: R01HL040152
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: September 1987
• Est. completion date: July 1992

Study information

• Verified date: May 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal and hypertensive pregnancy.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1992
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Pre-Eclampsia
• Pregnancy Toxemias

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (19)

August P, Lenz T, Ales KL, Druzin ML, Edersheim TG, Hutson JM, Müller 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pitarresi TM, Rubattu S, Heinrikson R, Sealey JE. Reversible cryoactivation of recombinant human prorenin. J Biol Chem. 1992 Jun 15;267(17):11753-9. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references