Cardiovascular DiseasesNCT00005394
Diagnosis/Pathophysiology of Glucocorticoid Remediable Aldosteronism Hypertension
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1995to Jul 2000
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients.
Read the detailed description
DESIGN NARRATIVE:
The spectrum of the severity and the natural history of the disorder was characterized. Modifying environmental and genetic factors important in regulation of blood pressure were determined. Also, renal physiology was studied in GRA patients to determine how these patients escaped hypokalemia in spite of mineralocorticoid excess. There were four specific aims including: 1) to determine the natural history and prevalence of GRA in various hypertensive populations, 2) to characterize the magnitude of effect imparted on blood pressure by inheritance of GRA and the sources of variation in phenotype expression of the hypertension, 3) to investigate the renal and hormonal mechanisms regulating potassium conservation and loss in GRA, and 4) to characterize the disequilibrium of GRA with Irish and Scottish descent and specific alleles of the aldosterone synthase gene.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1995
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard Lifton, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005394
- Sponsor's protocol ID
- 4300
- Other IDs
- R01HL053693
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Litchfield WR, Coolidge C, Silva P, Lifton RP, Fallo F, Williams GH, Dluhy RG. Impaired potassium-stimulated aldosterone production: a possible explanation for normokalemic glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 May;82(5):1507-10. doi: 10.1210/jcem.82.5.3964.
PubMed 9141541Litchfield WR, Anderson BF, Weiss RJ, Lifton RP, Dluhy RG. Intracranial aneurysm and hemorrhagic stroke in glucocorticoid-remediable aldosteronism. Hypertension. 1998 Jan;31(1 Pt 2):445-50. doi: 10.1161/01.hyp.31.1.445.
PubMed 9453343Litchfield WR, New MI, Coolidge C, Lifton RP, Dluhy RG. Evaluation of the dexamethasone suppression test for the diagnosis of glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 Nov;82(11):3570-3. doi: 10.1210/jcem.82.11.4381.
PubMed 9360508
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis/Pathophysiology of Glucocorticoid Remediable Aldosteronism Hypertension
- ClinicalTrials.gov ID
- NCT00005394
- Acronym / sponsor ID
- 4300
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1995
- Study completion
- Jul 2000 (actual)
- First posted
- 26 May 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.
To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients.
Detailed description
DESIGN NARRATIVE:
The spectrum of the severity and the natural history of the disorder was characterized. Modifying environmental and genetic factors important in regulation of blood pressure were determined. Also, renal physiology was studied in GRA patients to determine how these patients escaped hypokalemia in spite of mineralocorticoid excess. There were four specific aims including: 1) to determine the natural history and prevalence of GRA in various hypertensive populations, 2) to characterize the magnitude of effect imparted on blood pressure by inheritance of GRA and the sources of variation in phenotype expression of the hypertension, 3) to investigate the renal and hormonal mechanisms regulating potassium conservation and loss in GRA, and 4) to characterize the disequilibrium of GRA with Irish and Scottish descent and specific alleles of the aldosterone synthase gene.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 13 May 2016.
- Background: PubMed 9141541Litchfield WR, Coolidge C, Silva P, Lifton RP, Fallo F, Williams GH, Dluhy RG. Impaired potassium-stimulated aldosterone production: a possible explanation for normokalemic glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 May;82(5):1507-10. doi: 10.1210/jcem.82.5.3964.
- Background: PubMed 9453343Litchfield WR, Anderson BF, Weiss RJ, Lifton RP, Dluhy RG. Intracranial aneurysm and hemorrhagic stroke in glucocorticoid-remediable aldosteronism. Hypertension. 1998 Jan;31(1 Pt 2):445-50. doi: 10.1161/01.hyp.31.1.445.
- Background: PubMed 9360508Litchfield WR, New MI, Coolidge C, Lifton RP, Dluhy RG. Evaluation of the dexamethasone suppression test for the diagnosis of glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 Nov;82(11):3570-3. doi: 10.1210/jcem.82.11.4381.
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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.
Richard Lifton
Yale University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT00005394, which also lists 3 linked publications.
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 13 May 2016.