Heart Defects, CongenitalNCT00000107
Body Water Content in Cyanotic Congenital Heart Disease
An observational study of Heart Defects, Congenital, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. Read more about this study
- Who is it for?
- Ages 17 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 17 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Resting blood pressure below 140/90
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. The purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. The study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.
- Conditions
- Heart Defects, Congenital
- Keywords
- Cyanotic Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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
- Case-control
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000107
- Sponsor's protocol ID
- NCRR-M01RR00109-0737
- Other IDs
- M01RR000109
- Status last verified
- Dec 2003
- First submitted
- 18 Jan 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Water Content in Cyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00000107
- Acronym / sponsor ID
- NCRR-M01RR00109-0737
- Conditions
- Heart Defects, Congenital
- Keywords
- Cyanotic Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 19 Jan 2000 (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.
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. The purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. The study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Resting blood pressure below 140/90
Key exclusion criteria (0 listed)
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Defects, Congenital, run by National Center for Research Resources (NCRR) 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 1 inclusion and 0 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 24 Jun 2005. 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 24 Jun 2005.