Clincosm LogoSign in Get a demo

Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03255044
Collaborator
(none)
85
Enrollment
1
Location
2
Arms
21.5
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
Actual Study Start Date :
Jun 15, 2017
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lipophilic statin

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

Drug: Atorvastatin
Atorvastatin administered as well as standard heart failure therapy
Other Names:
  • standard heart failure therapy

    • Other: guideline directed therapy
    standard heart failure therapy
    Active Comparator: Hydrophilic statin

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

    Drug: Rosuvastatin
    Rosuvastatin administered as well as standard heart failure therapy
    Other Names:
  • standard heart failure therapy

    • Other: guideline directed therapy
    standard heart failure therapy

    Outcome Measures

    Primary Outcome Measures

    1. Left Ventricular Ejection Fraction (LVEF) [6 months]

    2. Left Ventricular End-diastolic volume (LVEDV) [6 months]

    3. Left Ventricular End-systolic volume (LVESV) [6 months]

    4. cardiac markers [6 months]

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

    Secondary Outcome Measures

    1. Minnesota Living with Heart Failure Questionnaire( MLHFQ) [6 months]

    2. Packer composite outcome [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 Outcome Measures

    1. Incidence of major adverse cardiac events [6 months]

      Cardiovascular death All cause death Non- fatal myocardial infarction Stroke

    2. Incidence of Hospitalization [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Hospital Cardiology Rehab Unit Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nouran Omar, Assistant Lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03255044
    Other Study ID Numbers:
    • 48
    First Posted:
    Aug 21, 2017
    Last Update Posted:
    Jan 9, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nouran Omar, Assistant Lecturer, Ain Shams University
    statin
    hydrophilic
    lipophilic
    Additional relevant MeSH terms:
    Heart Failure
    Atorvastatin
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Jan 9, 2020