Back to resultsComparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin
Rosuvastatin
guideline directed therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring statin, hydrophilic, lipophilic
Eligibility Criteria
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
Sites / Locations
- Ain Shams University Hospital Cardiology Rehab Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lipophilic statin
Hydrophilic statin
Arm Description
Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
Outcomes
Primary Outcome Measures
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular End-diastolic volume (LVEDV)
Left Ventricular End-systolic volume (LVESV)
cardiac markers
NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
Secondary Outcome Measures
Minnesota Living with Heart Failure Questionnaire( MLHFQ)
Packer composite outcome
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255044
Brief Title
Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
Official Title
Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
statin, hydrophilic, lipophilic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipophilic statin
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
Arm Title
Hydrophilic statin
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
standard heart failure therapy
Intervention Description
Atorvastatin administered as well as standard heart failure therapy
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
standard heart failure therapy
Intervention Description
Rosuvastatin administered as well as standard heart failure therapy
Intervention Type
Other
Intervention Name(s)
guideline directed therapy
Intervention Description
standard heart failure therapy
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction (LVEF)
Time Frame
6 months
Title
Left Ventricular End-diastolic volume (LVEDV)
Time Frame
6 months
Title
Left Ventricular End-systolic volume (LVESV)
Time Frame
6 months
Title
cardiac markers
Description
NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Minnesota Living with Heart Failure Questionnaire( MLHFQ)
Time Frame
6 months
Title
Packer composite outcome
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incidence of major adverse cardiac events
Description
Cardiovascular death
All cause death
Non- fatal myocardial infarction
Stroke
Time Frame
6 months
Title
Incidence of Hospitalization
Description
Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University Hospital Cardiology Rehab Unit
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33294980
Citation
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.
Results Reference
derived
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Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
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