Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255044
• Other study ID #: 48
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Atorvastatin
Atorvastatin administered as well as standard heart failure therapy
• Rosuvastatin
Rosuvastatin administered as well as standard heart failure therapy

Other:
• guideline directed therapy
standard heart failure therapy

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital Cardiology Rehab Unit	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of major adverse cardiac events	Cardiovascular death; All cause death; Non- fatal myocardial infarction; Stroke	6 months
Other	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
Primary	Left Ventricular Ejection Fraction (LVEF)		6 months
Primary	Left Ventricular End-diastolic volume (LVEDV)		6 months
Primary	Left Ventricular End-systolic volume (LVESV)		6 months
Primary	cardiac markers	NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)	6 months
Secondary	Minnesota Living with Heart Failure Questionnaire( MLHFQ)		6 months
Secondary	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