Trial Outcomes & Findings for Statin Therapy in Heart Failure: Potential Mechanisms of Benefit (NCT NCT00233480)

NCT ID: NCT00233480

Last Updated: 2020-03-20

Results Overview

Left ventricular ejection fraction was assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 27 participants
• Primary outcome timeframe: baseline and three months
• Results posted on: 2020-03-20

Participant Flow

Participant milestones

Measure	Active Treatment atorvastatin 10mg QD x 3 months	Placebo matched placebo QD x 3 months
Overall Study STARTED	14	13
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Active Treatment atorvastatin 10mg QD x 3 months	Placebo matched placebo QD x 3 months
Overall Study Underwent status II heart transplant	0	1

Baseline Characteristics

Statin Therapy in Heart Failure: Potential Mechanisms of Benefit

Baseline characteristics by cohort

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 14 • n=5 Participants	49 years STANDARD_DEVIATION 17 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and three months

Left ventricular ejection fraction was assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

Outcome measures

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months
LVEF (Left Ventricular Ejection Fraction) Baseline LVEF	24 percent ejection fraction Standard Error 6	28 percent ejection fraction Standard Error 7
LVEF (Left Ventricular Ejection Fraction) 3 month LVEF	25 percent ejection fraction Standard Error 6	24 percent ejection fraction Standard Error 7

PRIMARY outcome

Timeframe: Baseline and three months

Population: Eighteen subjects had baseline and final sympathetic microneurographic tracings that were technically adequate for analysis. Reasons for inadequate microneurographic tracing were: 1) inability of investigators to locate sympathetic nerve on baseline or final study; or 2) inability of patient to tolerate discomfort of the procedure.

Outcome measures

Measure	Active Treatment n=9 Participants atorvastatin 10mg QD x 3 months	Placebo n=9 Participants matched placebo QD x 3 months
Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) Baseline	43 bursts per minute Standard Error 3	39 bursts per minute Standard Error 3
Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) Three months	36 bursts per minute Standard Error 5	38 bursts per minute Standard Error 3

SECONDARY outcome

Timeframe: Baseline and three months

The end-diastolic dimension of the left ventricle (in mm) was measured with 2D echocardiography performed by experienced technicians using Acuson Sequoia Echocardiography System

Outcome measures

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months
Left Ventricular End-diastolic Dimension (LVEDD) Baseline LVEDD	65 Millimeters (mm) Standard Error 12	28 Millimeters (mm) Standard Error 7
Left Ventricular End-diastolic Dimension (LVEDD) Three months LVEDD	25 Millimeters (mm) Standard Error 6	24 Millimeters (mm) Standard Error 7

SECONDARY outcome

Timeframe: Baseline, 3 months

B-type natriuretic peptide, measured pg/mL at baseline and post-treatment

Outcome measures

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months
Cardiac Biomarker Level BNP Baseline	175 pg/mL Interval 36.0 to 472.0	66 pg/mL Interval 29.0 to 154.0
Cardiac Biomarker Level BNP Three Months	107 pg/mL Interval 34.0 to 173.0	67 pg/mL Interval 21.0 to 299.0

SECONDARY outcome

Timeframe: Baseline, Three months

Outcome measures

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months
High-sensitivity C-reactive Protein (hsCRP) as a Cardiac Biomarker Baseline	1.6 mg/L Interval 0.6 to 4.4	1.9 mg/L Interval 1.0 to 3.0
High-sensitivity C-reactive Protein (hsCRP) as a Cardiac Biomarker Three months	1.9 mg/L Interval 0.05 to 5.7	3.4 mg/L Interval 1.1 to 5.9

SECONDARY outcome

Timeframe: Baseline, Three months

Participants with cTnI ≥0.04 ng/mL

Outcome measures

Measure	Active Treatment n=14 Participants atorvastatin 10mg QD x 3 months	Placebo n=12 Participants matched placebo QD x 3 months
Cardiac Troponin I (cTnI) Baseline	8 percent of participants	21 percent of participants
Cardiac Troponin I (cTnI) Three Months	0 percent of participants	15 percent of participants

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tamara B Horwich, MD

Ahmanson-UCLA Cardiomyopathy Center

Phone: 310-825-8676

Email: thorwich@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place