NCT00208767

Brief Summary

The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan will increase the blood levels of markers responsible for repair of the vessel wall, reduce oxidation and inflammation, improve the function of the blood vessels, and arrest or slow down the progression of atherosclerosis over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

September 19, 2014

Completed
Last Updated

December 8, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Results QC Date

September 12, 2014

Last Update Submit

November 9, 2015

Conditions

Carotid Artery DiseasesAtherosclerosis

Keywords

Angiotensin receptor blockadeOxidative stressEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years

    The PI will measure carotid artery thickening with magnetic resonance imaging.

    Baseline, 2 years

Study Arms (2)

Valsartan

ACTIVE COMPARATOR

Valsartan titrated up to 320 mg orally daily

Drug: Valsartan

Placebo

PLACEBO COMPARATOR

Patients received a placebo instead of Valsartan

Drug: Placebo

Interventions

ValsartanDRUG

Valsartan was titrated to a target dose of 320 mg orally daily

Also known as: Diovan is a brand name of Valsartan
Valsartan
PlaceboDRUG

A matched placebo pill will be given orally daily.

Placebo

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 0.65 mm intima-media thickness of the carotid artery measured by ultrasound
  • Males aged 21-80 years or women without child bearing potential up to age 80
  • Can be on concomitant therapy with aspirin, thiazide diuretics, calcium antagonists (for treatment of hypertension), or beta-receptor antagonists.
  • May be on statin if on stable dose for at least 2 months before recruitment

You may not qualify if:

  • Angiotensin-converting enzyme (ACE) inhibitor or ARB therapy in the previous 3 months.
  • Initiation or change in dose of statin therapy within 2 months before the study
  • Inability to return to Emory for follow-up blood drawing and MR imaging
  • Age \< 21 or \> 80 years
  • Premenopausal females with potential for pregnancy
  • Current neoplasm
  • Chronic renal failure \[creatinine \> 2.5 mg/dL\]
  • Diabetes with hemoglobin (Hb) A1c \> 8.5
  • Anticipated change in lipid lowering therapy
  • Inability to give informed consent
  • Blood pressure \> 140 mmHg systolic and \> 90 mmHg diastolic
  • Low-density lipoprotein (LDL) cholesterol level \>130 mg/dl
  • Acute coronary syndrome within 2 months
  • Acute cerebrovascular accident within 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Carotid Artery DiseasesAtherosclerosis

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Results Point of Contact

Title
Dr. Arshed Quyyumi
Organization
Emory University School of Medicine
aquyyum@emory.edu
404-727-3655

Study Officials

  • Arshed Quyyumi, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 8, 2015

Results First Posted

September 19, 2014

Record last verified: 2015-11

Locations

US(1)