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

NCT05072054 | Unknown Phase 4

• 1 other identifier: PGIMER-CV-2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Atorvastatin; Rosuvastatin; Heart failure

Outcome Measures

Primary Outcomes (2)

• To compare the effect of atorvastatin and rosuvastatin on LVEF

  Change from baseline in Left ventricular ejection fraction (LVEF) measured by 2D Echocardiography after atorvastatin or rosuvastatin treatment

  Measurements at enrolment (baseline), 3 month and 6 months

• To compare the effect of atorvastatin and rosuvastatin on NT-ProBNP

  Change from baseline in NT-ProBNP (cardiac marker) after atorvastatin or rosuvastatin treatment.

  Measurements at enrolment (baseline), 3 months and 6 months

Secondary Outcomes (6)

• To compare the effect of atorvastatin and rosuvastatin on IL-6

  Measurements at enrolment (baseline) and 6 months

• To compare the effect of atorvastatin and rosuvastatin on hsCRP

  Measurements at enrolment (baseline), 3 month and 6 months

• To compare the effect of atorvastatin and rosuvastatin on Minnesota living with heart failure questionnaire (MLHFQ)

  Measurements at enrolment (baseline), 3 month and 6 months

• To compare the effect of atorvastatin and rosuvastatin on 6-minute walk test (6MWT)

  Measurements at enrolment (baseline), 3 month and 6 months

• Compare incidence of hospitalization for worsening of heart failure at 6 months in atorvastatin and rosuvastatin group

  Analysis at 6 months

Study Arms (2)

Atorvastatin arm

EXPERIMENTAL

Tablet Atorvastatin 40mg once daily at bed-time given for 6 months

Drug: Atorvastatin Oral Tablet

Rosuvastatin arm

ACTIVE COMPARATOR

Tablet Rosuvastatin 20mg once daily at bed-time given for 6 months

Drug: Rosuvastatin Oral Tablet

Interventions

Atorvastatin Oral Tablet DRUG

Atorvastatin 40 mg

Atorvastatin arm

Rosuvastatin Oral Tablet DRUG

Rosuvastatin 20 mg

Rosuvastatin arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either gender,18-65 years of age
• Left ventricular ejection fraction \<40% as assessed by 2D echocardiography
• NYHA class II-III
• CHF patients currently optimized on standard treatment for at least 1 month before enrolment and on an OPD basis treatment
• Ready to give written informed consent
• Willing to comply with the study protocol

You may not qualify if:

• Known hypersensitivity to statins
• NYHA class IV patient
• Serum creatinine \>3 mg/dl
• Significant liver disease: SGOT/SGPT \>3 times the upper limit of normal (ULN) or \>2.5 times the ULN in symptomatic patients
• Patient on an enzyme inducer or inhibitor currently
• Any malignancy or patient on chemotherapeutic agents
• Pregnant or lactating females
• Patients who have participated in another trial within the past 3 months
• Patient with uncontrolled diabetes mellitus (HbA1c \>7 g%)/ uncontrolled hypertension (BP \>140/90 mmHg despite in ≥3 antihypertensive drugs)
• Patient with HIV/ HBV / HCV infection

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Ashish K Kakkar

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Kakkar, MD, DM

CONTACT

91-172-2755297; drashishkakkar@gmail.com

Rachna Rohilla, MD

CONTACT

rachna.rohilla20@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomized to two arms in ratio 1:1 using computer-generated random list. Patients, investigator and care provider will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pharmacology

Model Details: Randomized, double-blind clinical study

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: October 16, 2019
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)