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CompletedNCT00005456Updated May 13, 2016

Hypertensive and Normal Pregnancy--Calcium Metabolism and Renin-Angiotensin - SCOR in Hypertension

An observational study in Cardiovascular Diseases, Heart Diseases and Hypertension, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
01

Study summary

To study calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy.

Read the detailed description

BACKGROUND:

Beginning in Fiscal Year 1975, the multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy began in December, 1990.

DESIGN NARRATIVE:

A longitudinal study was performed on normal pregnant women and women with chronic hypertension who had a high incidence of superimposed preeclampsia. In a previous study, the investigators had demonstrated that preeclampsia was associated with reduced urinary excretion of calcium and with lower plasma renin activity (PRA) compared with normal pregnancy. The goal of the investigators was to identify the metabolic and cellular basis for these alterations in calcium homeostasis and in the renin angiotensin system. They tested two hypotheses. The first hypothesis was that diminished placental and/or renal production of 1,25-dihydroxyvitamin D, leading to lower serum calcium, higher parathyroid hormone, and increased renal tubular reabsorption of calcium, was the metabolic basis for hypocalciuria in preeclampsia. The second hypothesis was that lower PRA in preeclampsia was due to systemic and renal vasoconstriction with hypertension and diminished natriuresis.

Serial measurements of 1,25-dihydroxyvitamin D, parathyroid hormone, serum ionized calcium, PRA, estradiol and progesterone, and urinary calcium and electrolytes were obtained, particularly at the onset of preeclampsia. Acute renal hemodynamic studies were also performed in women with preeclampsia and in gestational age matched normals. The studies investigated the relationships among glomerular filtration rate, renal blood flow, parathyroid hormone, vitamin D, atrial natriuretic factor, renin, estradiol and progesterone, and sodium and calcium excretion during infusion of inulin and PAH with either saline or calcium chloride.

Intracellular free calcium concentration in platelets and lymphocytes of pregnant women participating in longitudinal and acute renal hemodynamic studies were also measured. Basal and stimulated (with angiotensin II, ionomycin and thrombin), intracellular free calcium concentrations were compared in normal and hypertensive pregnant women and correlated with calcium regulatory hormones, plasma renin activity and hypertension.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

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Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
  • Eclampsia
  • Pre-Eclampsia
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Blank SG, Helseth G, Pickering TG, West JE, August P. How should diastolic blood pressure be defined during pregnancy? Hypertension. 1994 Aug;24(2):234-40. doi: 10.1161/01.hyp.24.2.234. PubMed 8039849 ↗
  • 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. PubMed 8027239 ↗
  • Baylis C, Beinder E, Suto T, August P. Recent insights into the roles of nitric oxide and renin-angiotensin in the pathophysiology of preeclamptic pregnancy. Semin Nephrol. 1998 Mar;18(2):208-30. PubMed 9541274 ↗
  • Hojo M, August P. Calcium metabolism in normal and hypertensive pregnancy. Semin Nephrol. 1995 Nov;15(6):504-11. PubMed 8588110 ↗
  • 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. PubMed 7707813 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 1990 and a completion of Nov 1995. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2000
First posted
May 26, 2000
Start
Dec 1990
CompletionActual
Nov 1995
Last update
May 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005456
First posted
May 26, 2000
Start date
Dec 1990
Completion
Nov 1995
Last update
May 13, 2016

Study contacts

Phyllis August
Weill Medical College of Cornell University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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