NCT00001629

Brief Summary

The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 1997

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

June 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Angiotensin AT-1 ReceptorAngiotensin Receptor AntagonistAtherosclerosisBlood FlowCold Pressor TestEndotheliumExerciseCoronary Artery DiseaseHeart Failure

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate. Women on chronic estrogen therapy are eligible for the study. Patients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure. No patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors.

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)

  • Cockcroft JR, Sciberras DG, Goldberg MR, Ritter JM. Comparison of angiotensin-converting enzyme inhibition with angiotensin II receptor antagonism in the human forearm. J Cardiovasc Pharmacol. 1993 Oct;22(4):579-84. doi: 10.1097/00005344-199310000-00011.

    PMID: 7505360BACKGROUND
  • Goldberg MR, Tanaka W, Barchowsky A, Bradstreet TE, McCrea J, Lo MW, McWilliams EJ Jr, Bjornsson TD. Effects of losartan on blood pressure, plasma renin activity, and angiotensin II in volunteers. Hypertension. 1993 May;21(5):704-13. doi: 10.1161/01.hyp.21.5.704.

    PMID: 8491505BACKGROUND
  • Sudhir K, MacGregor JS, Gupta M, Barbant SD, Redberg R, Yock PG, Chatterjee K. Effect of selective angiotensin II receptor antagonism and angiotensin converting enzyme inhibition on the coronary vasculature in vivo. Intravascular two-dimensional and Doppler ultrasound studies. Circulation. 1993 Mar;87(3):931-8. doi: 10.1161/01.cir.87.3.931.

    PMID: 8383016BACKGROUND

MeSH Terms

Conditions

AtherosclerosisHeart FailureHypertensionMyocardial InfarctionMotor ActivityCoronary Artery Disease

Interventions

Angiotensin II Type 1 Receptor Blockers

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesMyocardial IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehaviorCoronary Disease

Intervention Hierarchy (Ancestors)

Angiotensin Receptor AntagonistsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

July 1, 1997

Study Completion

September 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-06

Locations