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Completed

NCT Number: NCT03255044

Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospital Cardiology Rehab Unit

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

atorvastatin

Drug

Atorvastatin administered as well as standard heart failure therapy

Other names: standard heart failure therapy

Rosuvastatin

Drug

Rosuvastatin administered as well as standard heart failure therapy

Other names: standard heart failure therapy

guideline directed therapy

Other

standard heart failure therapy

Primary outcomes

  1. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 6 months

  2. Left Ventricular End-diastolic volume (LVEDV)

    Time frame: 6 months

  3. Left Ventricular End-systolic volume (LVESV)

    Time frame: 6 months

  4. cardiac markers

    Time frame: 6 months

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

Secondary outcomes

  1. Minnesota Living with Heart Failure Questionnaire( MLHFQ)

    Time frame: 6 months

  2. Packer composite outcome

    Time frame: 6 months

    • Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment: markedly/moderately improved (or both) but did not experience any major adverse clinical events during the course of the trial (death or hospitalization).
    • Patients are considered worse if they experienced a major clinical event during the duration of treatment or reported worsening of their NYHA class or global assessment at the final visit.
    • Patients are considered unchanged if they are neither improved nor worse.

Other outcomes

  1. Incidence of major adverse cardiac events

    Time frame: 6 months

    • Cardiovascular death
    • All cause death
    • Non- fatal myocardial infarction
    • Stroke

  2. Incidence of Hospitalization

    Time frame: 6 months

    Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2017
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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