CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
atorvastatin +1 moredrug
Likely dose
Atorvastatin 10 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years old
  • ✓LVEF ≤35% documented by echocardiography, radionuclide ventriculography, gated SPECT, or contrast ventriculography within past 6 months
  • ✓Symptomatic heart failure (NYHA class II-IV) or NYHA class I with history of symptomatic HF in the last year
  • ✓Stable doses of optimal heart failure medical therapy, unless documented contraindication
Key exclusion· 9
  • ✕Ischemic etiology of heart failure (angiographic >50% lesion in major epicardial vessels, history of MI, revascularization, or significant perfusion defect)
  • ✕Clinical indication for statin treatment (coronary artery, cerebrovascular, or peripheral vascular disease)
  • ✕Major cardiovascular event or surgical procedure within past 8 weeks
  • ✕LDL <70 mg/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233480
NCT00233480Phase 4Completed
CompareCT.gov

A Double-blind Randomized, Placebo-Controlled, Single-Center Study to Assess the Impact of Statins on the Autonomic Nervous System and Cardiac Structure/Function in Non-Ischemic Heart Failure

University of California, Los Angeles·interventional·Posted Oct 5, 2005·Updated Mar 20, 2020

In Brief

A Phase 4 clinical trial evaluating atorvastatin and placebo for Heart Failure, Congestive. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The goal of the investigators' study is to further understand the potentially beneficial effects of statin therapy in patients with heart failure. It is hypothesized that statins will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic nervous system and 3) decrease immune activation in heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive
CountriesUnited States
CollaboratorsPfizer, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartAug 1, 2005
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.7 years ago

Interventions

atorvastatindrug

atorvastatin 10mg PO QD

placebodrug

matched placebo Qd x 3 months