NCT00001741

Brief Summary

The renin angiotensin system is a complex process involving hormones and enzymes that regulate blood volume and blood pressure. The hormone angiotensin II is responsible for making blood vessels narrow or constrict. Angiotensin II is found in the blood and can attach to special sites called receptors on blood vessel walls. These receptors are programmed to accept angiotensin II and cause a constriction of the blood vessel. This function is found in the genetic information of each individual person. Occasionally patients have changes in their genes related to angiotensin II receptors. These changes may result in the receptors acting differently to angiotensin II, which may affect the function of blood vessels. This study is designed to improve researchers understanding of the physiological effects on blood vessels associated with mutations of the genes responsible for angiotensin II receptor function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Angiotensin II ReceptorPolymorphism, GeneticVascular ToneAngiotensin IILosartan

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients aged 21 or older with chronic orthostatic intolerance will be included. There will be no exclusion from participation in the study on the basis of ethnicity/race. Patients will be recruited in the Cardiology Branch outpatient clinic, Dr. David Goldstein (Chief Neurocardiology Section, NINDS, NIH), or from outside physicians. Children will be excluded from the study because of inability in obtaining informed consent. Cognitively impaired individuals, prisoners, or other institutionalized persons will not be able to participate.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Rigat B, Hubert C, Alhenc-Gelas F, Cambien F, Corvol P, Soubrier F. An insertion/deletion polymorphism in the angiotensin I-converting enzyme gene accounting for half the variance of serum enzyme levels. J Clin Invest. 1990 Oct;86(4):1343-6. doi: 10.1172/JCI114844.

    PMID: 1976655BACKGROUND
  • Cambien F, Poirier O, Lecerf L, Evans A, Cambou JP, Arveiler D, Luc G, Bard JM, Bara L, Ricard S, et al. Deletion polymorphism in the gene for angiotensin-converting enzyme is a potent risk factor for myocardial infarction. Nature. 1992 Oct 15;359(6396):641-4. doi: 10.1038/359641a0.

    PMID: 1328889BACKGROUND
  • Alderman MH, Madhavan S, Ooi WL, Cohen H, Sealey JE, Laragh JH. Association of the renin-sodium profile with the risk of myocardial infarction in patients with hypertension. N Engl J Med. 1991 Apr 18;324(16):1098-104. doi: 10.1056/NEJM199104183241605.

    PMID: 1759997BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 1, 1997

Study Completion

April 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-04

Locations