NCT00769210

Brief Summary

Our proposed research will examine whether treatment with simvastatin alters expression and activity of monocyte TF, whether polymorphisms in the TF gene alter the therapeutic effect and what effect treatment has on inflammatory markers in heart failure. The results of this study may assist in tailoring statin therapy to specific characteristics, such as inflammatory state, of heart failure patients. If treatment with simvastatin significantly lowers TF expression, this may reduce the risk of thromboembolic events in patients with heart failure, thus reducing mortality and morbidity. If the treatment effect varies based on the TF genotype, this may define an identifiable population in whom statin therapy may be more beneficial than the population as a whole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1 heart-failure

Timeline
Completed

Started May 2005

Longer than P75 for early_phase_1 heart-failure

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

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

3.2 years

First QC Date

December 22, 2007

Last Update Submit

March 29, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Measure the effect of simvastatin treatment on the expression and activity of TF in patients with heart failure.

    May 2005-June 2008

Secondary Outcomes (1)

  • Determine if polymorphisms in the gene coding for TF affect the impact of simvastatin therapy on tissue factor expression

    May 2005-June 2008

Study Arms (1)

A

EXPERIMENTAL
Drug: Simvastatin

Interventions

SimvastatinDRUG

Simvastatin 40 mg tablet

Also known as: Zocor
A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 to 85 years
  • Symptomatic heart failure, NYHA class I to III
  • Left ventricular ejection fraction \< 0.40
  • Give written informed consent

You may not qualify if:

  • Pregnant or lactating women. Women in reproductive years must have an active form of contraception (oral contraceptives, IUD, diaphragm, condoms or surgical sterilization) and a negative pregnancy test at study entry.
  • Heart failure as the results of any of the following conditions:
  • active myocarditis
  • congenital heart disease
  • uncorrected, hemodynamically significant stenotic valvular disease
  • NYHA functional class IV symptoms
  • Current or previous treatment with a statin Patients with plasma LDL-C concentrations higher than 130 mg/dL and any of the following conditions
  • Ischemic cardiomyopathy
  • Previous cardiovascular event (CVA, ACS event)
  • Known coronary artery disease
  • Unstable angina
  • Presence of any progressive systemic disease that would be expected to impact the patient's outcome over the time course of the study
  • Uncorrected endocrine disorders including primary aldosteronism, pheochromocytoma, hyperthyroidism, hypothyroidism, brittle type 1 diabetes mellitus
  • Inherited disorders of lipid metabolism
  • Evidence of significant renal disease (serum creatinine \> 2.5 mg/dl), or hepatic disease (transaminase levels \> three fold higher than laboratory normal)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Mark Munger, PharmD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2007

First Posted

October 9, 2008

Study Start

May 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(1)