NCT03255044

Brief Summary

There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Jun 2017

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

June 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

August 10, 2017

Last Update Submit

January 6, 2020

Conditions

Heart Failure

Keywords

statinhydrophiliclipophilic

Outcome Measures

Primary Outcomes (4)

  • Left Ventricular Ejection Fraction (LVEF)

    6 months

  • Left Ventricular End-diastolic volume (LVEDV)

    6 months

  • Left Ventricular End-systolic volume (LVESV)

    6 months

  • cardiac markers

    NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)

    6 months

Secondary Outcomes (2)

  • Minnesota Living with Heart Failure Questionnaire( MLHFQ)

    6 months

  • Packer composite outcome

    6 months

Other Outcomes (2)

  • Incidence of major adverse cardiac events

    6 months

  • Incidence of Hospitalization

    6 months

Study Arms (2)

Lipophilic statin

ACTIVE COMPARATOR

Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.

Drug: AtorvastatinOther: guideline directed therapy

Hydrophilic statin

ACTIVE COMPARATOR

Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.

Drug: RosuvastatinOther: guideline directed therapy

Interventions

AtorvastatinDRUG

Atorvastatin administered as well as standard heart failure therapy

Also known as: standard heart failure therapy
Lipophilic statin
RosuvastatinDRUG

Rosuvastatin administered as well as standard heart failure therapy

Also known as: standard heart failure therapy
Hydrophilic statin
guideline directed therapyOTHER

standard heart failure therapy

Hydrophilic statinLipophilic statin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years (of both sexes)
  • diagnosed with stable chronic heart failure NYHA class II-III
  • ejection fraction \< 40 % as assessed by 2D echocardiography
  • who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.

You may not qualify if:

  • Known hypersensitivity to statin
  • Treatment with statins during the past month prior to study.
  • Serum creatinine \> 3 mg/dl
  • Significant liver disease: liver enzymes 2.5 folds the upper normal limit
  • Malignancy
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital Cardiology Rehab Unit

Cairo, Egypt

Location

Related Publications (1)

  • El Said NO, El Wakeel LM, Khorshid H, Darweesh EAG, Ahmed MA. Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study. Br J Clin Pharmacol. 2021 Jul;87(7):2855-2866. doi: 10.1111/bcp.14695. Epub 2021 Jan 3.

    PMID: 33294980DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

AtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 21, 2017

Study Start

June 15, 2017

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)