Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: Rosuvastatin; Drug: Atorvastatin; Other: guideline directed therapy

• Registration Number: NCT03255044
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrophilic statin	guideline directed therapy	Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
Lipophilic statin	guideline directed therapy	Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
Hydrophilic statin	Rosuvastatin	Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
Lipophilic statin	Atorvastatin	Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.

Primary Outcome Measures

Name	Time	Method
Left Ventricular End-systolic volume (LVESV)	6 months
Left Ventricular Ejection Fraction (LVEF)	6 months
Left Ventricular End-diastolic volume (LVEDV)	6 months
cardiac markers	6 months	NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)

Secondary Outcome Measures

Name	Time	Method
Minnesota Living with Heart Failure Questionnaire( MLHFQ)	6 months
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.

Trial Locations

Locations (1)

Ain Shams University Hospital Cardiology Rehab Unit; 🇪🇬 Cairo, Egypt