Marinobufagenin as a Target for DIGIBIND in Preeclampsia

NCT01328600 | Completed

• 2 other identifiers: 99990625906-AG-N259
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

Background:

• Preeclampsia is a combination of high blood pressure and other potentially life-threatening symptoms. Preeclampsia occurs in up to 10% of pregnancies and is a main cause of maternal and fetal death worldwide. Treatment is often difficult, and so far there is no specific and effective therapy. Researchers have been studying the body systems that regulate blood pressure. They have also studied drugs that can control certain blood chemicals that constrict blood vessels and increase blood pressure.
• DIGIBIND, a drug that lowers blood pressure, has been used to treat pre-eclampsia. Marinobufagenin (MBG), a chemical in the blood that constricts blood vessels, has been shown to be involved in pre-eclampsia. But researchers are still not certain whether DIGIBIND can be used to specifically target MBG. Researchers want to find out whether DIGIBIND acts against MBG specifically. This information may help them to develop better drugs to block MBG and lower blood pressure in women with preeclampsia. Objectives: \- To study whether the blood pressure treatment drug DIGIBIND specifically acts on marinobufagenin levels in the blood of pregnant women. Eligibility: \- Women between 18 and 50 years of age who are 34 to 39 weeks pregnant and have preeclampsia. Design:
• Participants will be screened with a physical examination, medical history, and blood and urine tests.
• Before delivery, participants will provide blood samples for testing and evaluation.
• Following delivery, participants will provide additional blood samples and samples of the placenta for testing and evaluation.
• No additional treatment, apart from the standard of care, will be provided as part of this protocol.

Conditions

Preeclampsia

Keywords

Placenta; Pregnancy; Hypertension; Supplementation; Antibody

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women (18-50 years), 34-39 weeks of fetal gestational age with preeclampsia as defined by American College of ObGyn criteria. This definition of PE includes:
• diastolic blood pressure of at least 90 mm Hg or
• a systolic blood pressure of at least 140 mm Hg, or
• a rise in the former of at least 15 mm Hg or in the latter of 30 mm Hg on at least two occasions 6 hours or more apart,
• proteinuria (presence of 300 mg or more of protein in a 24-hour urine collection or a protein concentration of 1 g or more per liter in at least two random urine specimens collected 6 hours or more apart) or
• edema (a generalized accumulation of fluid of greater than 1+ pitting edema after 12 hours of bed rest or weight gain of 5 pounds or more in 1 week), or
• both, induced by pregnancy after the 20th week of gestation, and sometimes earlier.
• Healthy pregnant women (18-50 years) 34-39 weeks of fetal gestational age as control subjects.
• Decision of investigator to terminate pregnancy via cesarean section (patient is in need of immediate delivery as soon as clinically appropriate)

You may not qualify if:

• Eclampsia, i.e., the occurrence of seizures not attributed to another cause during pregnancy
• Significant antecedent obstetrical problems that may interfere with study assessments or safe participation in the study
• Evidence of non-reassuring fetal well being
• Evidence of a lethal or life-threatening fetal anomaly
• Antecedent hypertension (hypertension secondary to preeclampsia, treated or untreated is allowed)
• Antecedent renal, hepatic, or autoimmune disease
• Medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
• Evidence on medical history/evaluation of use of or need for digitalis-like products currently or in the future
• Serum creatinine greater than or equal to 1.5 mg/dl
• Inability to understand and provide informed consent

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (3)

City Hospital No. 9

Saint Petersburg, Russia

Location

Pushlon Hospital

Saint Petersburg, Russia

Location

Veevolozhsk Hospital

Saint Petersburg, Russia

Location

Related Publications (3)

• Hamlyn JM, Ringel R, Schaeffer J, Levinson PD, Hamilton BP, Kowarski AA, Blaustein MP. A circulating inhibitor of (Na+ + K+)ATPase associated with essential hypertension. Nature. 1982 Dec 16;300(5893):650-2. doi: 10.1038/300650a0. No abstract available.

  PMID: 6292738 BACKGROUND

• Graves SW, Williams GH. An endogenous ouabain-like factor associated with hypertensive pregnant women. J Clin Endocrinol Metab. 1984 Dec;59(6):1070-4. doi: 10.1210/jcem-59-6-1070.

  PMID: 6092405 BACKGROUND

• Ludens JH, Clark MA, Kolbasa KP, Hamlyn JM. Digitalis-like factor and ouabain-like compound in plasma of volume-expanded dogs. J Cardiovasc Pharmacol. 1993;22 Suppl 2:S38-41. doi: 10.1097/00005344-199322002-00014.

  PMID: 7508024 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexei Y Bagrov, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 4, 2011
• Study Start: August 16, 2006
• Study Completion: July 29, 2014
• Last Updated: December 9, 2019

Record last verified: 2014-07-29

Locations

RU (3)