CardiomyopathyNCT00324402
Plasma Brain Natriuretic Peptide Levels in Pregnancy
An observational study of Cardiomyopathy and Pregnancy, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Pregnancy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women, 18-40
Who may be able to join
- women age 18 to 40
- second trimester of pregnancy
Who cannot join
- known cardiac or valvular disease,
- atrial fibrillation or other arrhythmia,
- pulmonary hypertension,
- chronic hypertension,
- hypertensive disorders of pregnancy,
- morbid obesity (BMI > 40 kg/meter squared)
Show all 11Show fewer
- history of sleep apnea
- multiple gestation
- known renal dysfunction
- medications known to affect cardiac function
- current or past abnormal echocardiogram
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127
About this study
To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.
Read the detailed description
The brain natriuretic peptide (BNP) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. The current literature contains limited and unreliable information regarding normal BNP values in pregnancy. After baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.
- Conditions
- Cardiomyopathy, Pregnancy
- Keywords
- brain natriuretic peptide, pregnancy, biomarker
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy pregnant women, 18-40 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startAug 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly A Sorensen, DO, Study chair, Oklahoma State University Center for Health SciencesJohn M Beal, DO, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324402
- Sponsor's protocol ID
- 2005008
- Status last verified
- Oct 2020
- First submitted
- 9 May 2006
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Brain Natriuretic Peptide Levels in Pregnancy
- ClinicalTrials.gov ID
- NCT00324402
- Acronym / sponsor ID
- 2005008
- Conditions
- Cardiomyopathy, Pregnancy
- Keywords
- brain natriuretic peptide, pregnancy, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Jun 2008 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.
Detailed description
The brain natriuretic peptide (BNP) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. The current literature contains limited and unreliable information regarding normal BNP values in pregnancy. After baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy pregnant women, 18-40 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women, 18-40
Key inclusion criteria (2 listed)
- women age 18 to 40
- second trimester of pregnancy
Key exclusion criteria (11 listed)
- known cardiac or valvular disease,
- atrial fibrillation or other arrhythmia,
- pulmonary hypertension,
- chronic hypertension,
- hypertensive disorders of pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Sorensen, DO study chair
Oklahoma State University Center for Health Sciences
John M Beal, DO principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Pregnancy, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.