Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Atorvastatin; Other: guideline directed therapy; Drug: Rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospital Cardiology Rehab Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: guideline directed therapy; standard heart failure therapy; Drug: Rosuvastatin; Rosuvastatin administered as well as standard heart failure therapy; Other Names: standard heart failure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnesota Living with Heart Failure Questionnaire( MLHFQ)		6 months
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac events	Cardiovascular death; All cause death; Non- fatal myocardial infarction; Stroke	6 months
Incidence of Hospitalization	Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..)	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: statin; hydrophilic; lipophilic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: 48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No