Comparison of Effects of Atorvastatin Versus Rosuvastatin on Cardiac Function in Heart Failure Patients

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Statins have a protective effect in patients with established heart failure because of their lipid-lowering and pleiotropic effects. There is no randomized controlled trial comparing lipophilic versus hydrophilic statins in these patients (head to head comparison). The best evidence so far is from a meta-analysis in which the authors did an adjusted indirect comparison between lipophilic statins and rosuvastatin and found that lipophilic statins were associated with significantly lower incidence of all-cause mortality, cardiovascular mortality, and hospitalization for worsening heart failure compared to rosuvastatin (hydrophilic statin) among patients with heart failure. So, the investigators plan to conduct a randomized controlled trial comparing the effects of atorvastatin and rosuvastatin on cardiac function in patients with heart failure with reduced ejection fraction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborator: Indian Council of Medical Research
• Treatments: Atorvastatin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Either gender,18-65 years of age

2. Left ventricular ejection fraction <40% as assessed by 2D echocardiography

3. NYHA class II-III

4. CHF patients currently optimized on standard treatment for at least 1 month before enrolment and on an OPD basis treatment

5. Ready to give written informed consent

6. Willing to comply with the study protocol

Exclusion Criteria:

1. Known hypersensitivity to statins

2. NYHA class IV patient

3. Serum creatinine >3 mg/dl

4. Significant liver disease: SGOT/SGPT >3 times the upper limit of normal (ULN) or >2.5 times the ULN in symptomatic patients

5. Patient on an enzyme inducer or inhibitor currently

6. Any malignancy or patient on chemotherapeutic agents

7. Pregnant or lactating females

8. Patients who have participated in another trial within the past 3 months

9. Patient with uncontrolled diabetes mellitus (HbA1c >7 g%)/ uncontrolled hypertension (BP >140/90 mmHg despite in ≥3 antihypertensive drugs)

10. Patient with HIV/ HBV / HCV infection