Cardiovascular DiseasesNCT00005149
Genetic and Environmental Determinants of Hypertension
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Utah.
Trial summary
To determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 1980to Nov 1992
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension.
Read the detailed description
BACKGROUND:
Essential hypertension is believed to be a heterogeneous group of disorders, the subtypes of which could be related to sodium sensitivity, obesity, diabetes, calcium intake and metabolism, the renin-angiotensin balance, or membrane cation transport. Essential hypertension aggregates in families. The syndromes leading to hypertension may involve shared genes, shared environmental factors, or both.
DESIGN NARRATIVE:
In 1980 a series of biochemical and physiological tests were initiated in the 2,548 persons in 98 extended pedigrees in Utah. Most of the subjects were obtained from three major pedigree types: stroke cluster pedigrees; coronary heart disease cluster pedigrees; and pedigrees of Utah Hypertension Detection and Follow-up Program high blood pressure probands. Data were collected on personal history, medical family history and genealogy, anthropometrics, standard and 32-lead electro- cardiograms, multiple blood pressure measurements during sitting, standing, lying, tilting, isometric hand grip exercise, bicycle exercise, venipuncture and mental arithmetic. Cation tests included sodium-lithium countertransport, lithium-potassium co-transport, intracellular sodium, potassium, magnesium, sodium-potassium ATP-ase pump activity and binding sites and plasma levels of sodium, potassium, magnesium, ionized calcium and digoxin-like pump inhibitor. Information was also collected on stress, exercise, plasma renin activity, and urinary kallikrein. Statistical and pedigree analysis were conducted.
The same tests were also performed on 600 new population-based hypertensive subjects on drug therapy and again four months after interruption of drug therapy. Tests were conduced for specific subtypes of high blood pressure among the 600 subjects using individual variables and multivariate combinations of variables. Three hundred nuclear families were screened to test for familiality of subtype indicators and to identify those high blood pressure subtype indicator variables needing detailed pedigree analysis.
One thousand sequentially-sampled persons were studied for major genes, DNA probe linkage, and gene-environment interactions as determinants of specific types of hypertension.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
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 startFeb 1980
- Study completionNov 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)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 University of UtahThe 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
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005149
- Sponsor's protocol ID
- 1020
- Other IDs
- R01HL024855
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 21 Jan 2016
- Results posted
- No
Publications
Smith JB, Price AL, Williams RR, Hentschel WM, Sprowell W, Hunt SC, Ash KO. A reproducible sodium-lithium countertransport assay: the outcome of changing key laboratory parameters. Clin Chim Acta. 1982 Jul 15;122(3):327-35. doi: 10.1016/0009-8981(82)90135-8.
PubMed 7105417Smith JB, Ash KO, Hentschel WM, Williams RR. A kinetic expression for sodium-lithium countertransport in human red cells. Clin Chim Acta. 1982 Jul 15;122(3):337-43. doi: 10.1016/0009-8981(82)90136-x.
PubMed 7105418Worley RJ, Hentschel WM, Cormier C, Nutting S, Pead G, Zelenkov K, Smith JB, Ash KO, Williams RR. Increased sodium-lithium countertransport in erythrocytes of pregnant women. N Engl J Med. 1982 Aug 12;307(7):412-6. doi: 10.1056/NEJM198208123070706. No abstract available.
PubMed 7088116Williams RR, Hunt SC, Kuida H, Smith JB, Ash KO. Sodium-lithium countertransport in erythrocytes of hypertension prone families in Utah. Am J Epidemiol. 1983 Sep;118(3):338-44. doi: 10.1093/oxfordjournals.aje.a113640.
PubMed 6613977Ash KO, Smith JB, Kemp JW, Lynch MB, Moody FG, Raymond JL, McKnight MR, Williams RR. The effect of diet on ouabain binding to erythrocytes from obese subjects. Clin Physiol Biochem. 1983;1(6):293-9.
PubMed 6094078Dadone MM, Hasstedt SJ, Hunt SC, Smith JB, Ash KO, Williams RR. Genetic analysis of sodium-lithium countertransport in 10 hypertension-prone kindreds. Am J Med Genet. 1984 Mar;17(3):565-77. doi: 10.1002/ajmg.1320170304.
PubMed 6585142Smith JB, Ash KO, Hunt SC, Hentschel WM, Sprowell W, Dadone MM, Williams RR. Three red cell sodium transport systems in hypertensive and normotensive Utah adults. Hypertension. 1984 Mar-Apr;6(2 Pt 1):159-66.
PubMed 6327514Smith JB, Ash KO, Hentschel WM, Sprowell WL, Williams RR. A simplified method for simultaneously determining countertransport and cotransport in human erythrocytes. Clin Chim Acta. 1984 Feb 28;137(2):169-77. doi: 10.1016/0009-8981(84)90177-3.
PubMed 6705232Jorde LB, Williams RR, Hunt SC. Lack of association of diagonal earlobe crease with other cardiovascular risk factors. West J Med. 1984 Feb;140(2):220-3.
PubMed 6730469Hunt SC, McCarron DA, Smith JB, Ash KO, Bristow MR, Williams RR. The relationship of plasma ionized calcium to cardiovascular disease endpoint and family history of hypertension. Clin Exp Hypertens A. 1984;6(8):1397-414. doi: 10.3109/10641968409044058.
PubMed 6499235Williams RR, Hunt SC, Dadone MM, Hasstedt S, Smith JB, Ash KO, Kuida H: Preliminary Analysis of Sodium-Lithium Countertransport and Blood Pressure in Utah Pedigrees. In: Topics In Pathophysiology Of Hypertension (Villarreal H, Sambhi MP, Eds). Boston: Martinus Nijhoff Publishers. pp 112-135, 1984
Williams RR, Dadone MM, Hunt SC, Jorde LB, Hopkins PN, Smith JB, Ash KO, Kuida H. The genetic epidemiology of hypertension: a review of past studies and current results for 948 persons in 48 Utah pedigrees. Prog Clin Biol Res. 1984;147:419-42. No abstract available.
PubMed 6377318Williams RR, Hunt SC, Dadone MM, Smith JB, Ash KO, Kuida K: Cation Flux and Other Possible Biological Markers of Genetically Predisposed Hypertension. In: Children's Blood Pressure, Report of the Eighty- Eighth Ross Conference on Pediatric Research (Filer LJ and Lauer RM, Eds). Columbus, Ohio: Ross Laboratories, pp 100-123, 1984
Smith JB, Ash KO, Sprowell WL, Hentschel WM, Williams RR. An improved non-radioisotopic method for measuring ouabain-sensitive Na+ efflux from erythrocytes. Clin Chim Acta. 1984 Nov 30;143(3):295-9. doi: 10.1016/0009-8981(84)90081-0. No abstract available.
PubMed 6094043Smith JB, Ash KO, Gregory MC, Sprowell WL, Hentschel WM, Williams RR. Hemodialysis does not affect erythrocyte sodium-lithium countertransport. Clin Chim Acta. 1984 Nov 30;143(3):275-9. doi: 10.1016/0009-8981(84)90077-9.
PubMed 6499221
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Environmental Determinants of Hypertension
- ClinicalTrials.gov ID
- NCT00005149
- Acronym / sponsor ID
- 1020
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1980
- Study completion
- Nov 1992
- 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 determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension.
Detailed description
BACKGROUND:
Essential hypertension is believed to be a heterogeneous group of disorders, the subtypes of which could be related to sodium sensitivity, obesity, diabetes, calcium intake and metabolism, the renin-angiotensin balance, or membrane cation transport. Essential hypertension aggregates in families. The syndromes leading to hypertension may involve shared genes, shared environmental factors, or both.
DESIGN NARRATIVE:
In 1980 a series of biochemical and physiological tests were initiated in the 2,548 persons in 98 extended pedigrees in Utah. Most of the subjects were obtained from three major pedigree types: stroke cluster pedigrees; coronary heart disease cluster pedigrees; and pedigrees of Utah Hypertension Detection and Follow-up Program high blood pressure probands. Data were collected on personal history, medical family history and genealogy, anthropometrics, standard and 32-lead electro- cardiograms, multiple blood pressure measurements during sitting, standing, lying, tilting, isometric hand grip exercise, bicycle exercise, venipuncture and mental arithmetic. Cation tests included sodium-lithium countertransport, lithium-potassium co-transport, intracellular sodium, potassium, magnesium, sodium-potassium ATP-ase pump activity and binding sites and plasma levels of sodium, potassium, magnesium, ionized calcium and digoxin-like pump inhibitor. Information was also collected on stress, exercise, plasma renin activity, and urinary kallikrein. Statistical and pedigree analysis were conducted.
The same tests were also performed on 600 new population-based hypertensive subjects on drug therapy and again four months after interruption of drug therapy. Tests were conduced for specific subtypes of high blood pressure among the 600 subjects using individual variables and multivariate combinations of variables. Three hundred nuclear families were screened to test for familiality of subtype indicators and to identify those high blood pressure subtype indicator variables needing detailed pedigree analysis.
One thousand sequentially-sampled persons were studied for major genes, DNA probe linkage, and gene-environment interactions as determinants of specific types of hypertension.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- 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 21 Jan 2016.
- Background: PubMed 7105417Smith JB, Price AL, Williams RR, Hentschel WM, Sprowell W, Hunt SC, Ash KO. A reproducible sodium-lithium countertransport assay: the outcome of changing key laboratory parameters. Clin Chim Acta. 1982 Jul 15;122(3):327-35. doi: 10.1016/0009-8981(82)90135-8.
- Background: PubMed 7105418Smith JB, Ash KO, Hentschel WM, Williams RR. A kinetic expression for sodium-lithium countertransport in human red cells. Clin Chim Acta. 1982 Jul 15;122(3):337-43. doi: 10.1016/0009-8981(82)90136-x.
- Background: PubMed 7088116Worley RJ, Hentschel WM, Cormier C, Nutting S, Pead G, Zelenkov K, Smith JB, Ash KO, Williams RR. Increased sodium-lithium countertransport in erythrocytes of pregnant women. N Engl J Med. 1982 Aug 12;307(7):412-6. doi: 10.1056/NEJM198208123070706. No abstract available.
- Background: PubMed 6613977Williams RR, Hunt SC, Kuida H, Smith JB, Ash KO. Sodium-lithium countertransport in erythrocytes of hypertension prone families in Utah. Am J Epidemiol. 1983 Sep;118(3):338-44. doi: 10.1093/oxfordjournals.aje.a113640.
- Background: PubMed 6094078Ash KO, Smith JB, Kemp JW, Lynch MB, Moody FG, Raymond JL, McKnight MR, Williams RR. The effect of diet on ouabain binding to erythrocytes from obese subjects. Clin Physiol Biochem. 1983;1(6):293-9.
- Background: PubMed 6585142Dadone MM, Hasstedt SJ, Hunt SC, Smith JB, Ash KO, Williams RR. Genetic analysis of sodium-lithium countertransport in 10 hypertension-prone kindreds. Am J Med Genet. 1984 Mar;17(3):565-77. doi: 10.1002/ajmg.1320170304.
- Background: PubMed 6327514Smith JB, Ash KO, Hunt SC, Hentschel WM, Sprowell W, Dadone MM, Williams RR. Three red cell sodium transport systems in hypertensive and normotensive Utah adults. Hypertension. 1984 Mar-Apr;6(2 Pt 1):159-66.
- Background: PubMed 6705232Smith JB, Ash KO, Hentschel WM, Sprowell WL, Williams RR. A simplified method for simultaneously determining countertransport and cotransport in human erythrocytes. Clin Chim Acta. 1984 Feb 28;137(2):169-77. doi: 10.1016/0009-8981(84)90177-3.
- Background: PubMed 6730469Jorde LB, Williams RR, Hunt SC. Lack of association of diagonal earlobe crease with other cardiovascular risk factors. West J Med. 1984 Feb;140(2):220-3.
- Background: PubMed 6499235Hunt SC, McCarron DA, Smith JB, Ash KO, Bristow MR, Williams RR. The relationship of plasma ionized calcium to cardiovascular disease endpoint and family history of hypertension. Clin Exp Hypertens A. 1984;6(8):1397-414. doi: 10.3109/10641968409044058.
- BackgroundWilliams RR, Hunt SC, Dadone MM, Hasstedt S, Smith JB, Ash KO, Kuida H: Preliminary Analysis of Sodium-Lithium Countertransport and Blood Pressure in Utah Pedigrees. In: Topics In Pathophysiology Of Hypertension (Villarreal H, Sambhi MP, Eds). Boston: Martinus Nijhoff Publishers. pp 112-135, 1984
- Background: PubMed 6377318Williams RR, Dadone MM, Hunt SC, Jorde LB, Hopkins PN, Smith JB, Ash KO, Kuida H. The genetic epidemiology of hypertension: a review of past studies and current results for 948 persons in 48 Utah pedigrees. Prog Clin Biol Res. 1984;147:419-42. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Utah.
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 21 Jan 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 NCT00005149, which also lists 62 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 21 Jan 2016.