Comparison of Effects of Atorvastatin Versus Rosuvastatin on Cardiac Function in Heart Failure Patients
NCT ID: NCT05072054
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2019-10-16
2022-08-31
Brief Summary
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Detailed Description
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Various randomized and non-randomized clinical trials have evaluated statins like Atorvastatin, Rosuvastatin, Simvastatin, Pitavastatin and reported improved clinical outcomes in patients with heart failure with reduced ejection fraction as well as heart failure with preserved ejection fraction. Similar benefits on improved cardiac function, reduced inflammation, and improved mortality have been seen in small randomized controlled trials (RCTs) with Atorvastatin. The two large RCTs - Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza cardiac (GISSI-HF) - which compared Rosuvastatin versus placebo, failed to show statistically significant benefits in mortality outcomes in heart failure patients compared to placebo, although CORONA trial did show a significant reduction in hospital admissions but not on mortality.
However, these two large trials only compared one statin i.e rosuvastatin versus placebo; which is a hydrophilic statin. Statin is not a uniform class of drugs. They differ in their pleiotropic effects based on lipophilic nature. There is evidence that lipophilic statins enter cells via passive diffusion and are widely distributed to various tissues including cardiac tissues where it exerts pleiotropic actions whereas uptake of hydrophilic statins is via carrier-mediated mechanisms and is restricted to the liver, thus reduced the capacity of non-lipid effects on extra-hepatic tissues.
Currently, there is no RCT comparing lipophilic statin versus hydrophilic statin (head to head comparison). The best evidence so far is from a meta-analysis which is an adjusted indirect comparison between lipophilic statins and rosuvastatin. They found that lipophilic statins were associated with a 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 and inflammation in patients with heart failure with reduced ejection fraction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Atorvastatin arm
Tablet Atorvastatin 40mg once daily at bed-time given for 6 months
Atorvastatin Oral Tablet
Atorvastatin 40 mg
Rosuvastatin arm
Tablet Rosuvastatin 20mg once daily at bed-time given for 6 months
Rosuvastatin Oral Tablet
Rosuvastatin 20 mg
Interventions
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Atorvastatin Oral Tablet
Atorvastatin 40 mg
Rosuvastatin Oral Tablet
Rosuvastatin 20 mg
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Ashish Kakkar
Associate Professor, Department of Pharmacology
Principal Investigators
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Ashish K Kakkar
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PGIMER-CV-2019
Identifier Type: -
Identifier Source: org_study_id