What is the clinical evidence from this study?

Study design: RCT. Population: dilated cardiomyopathy (DCM) (n=44). Intervention: carvedilol plus aliskiren vs. carvedilol alone. Primary outcome: TDS, ejection fraction, NYHA, SAS, end-diastolic volume, and BNP (p=<0.05).

June 10, 2021Open Access

Efficacy of Add-on Therapy with Carvedilol and the Direct Renin Inhibitor Aliskiren for Improving Cardiac Sympathetic Nerve Activity, Cardiac Function, Symptoms, Exercise Capacity and Brain Natriuretic Peptide in Patients with Dilated Cardiomyopathy

Q: What are the key findings of this study?

Combined therapy with carvedilol and aliskiren significantly improved cardiac sympathetic nerve activity, ejection fraction, symptoms, exercise capacity, and BNP compared to carvedilol alone (p<0.05).

TTTakuji ToyamaCardiac Imaging SKShu KasamaShiga University of Medical Science YMYusuke MiyaishiGunma Prefectural Cardiovascular Center

Key Result

Combined therapy with carvedilol and aliskiren significantly improved cardiac sympathetic nerve activity, ejection fraction, symptoms, exercise capacity, and BNP compared to carvedilol alone (p<0.05).

Study Design

Type

RCT (n=44)

Randomization

randomized

Structured PICO

Does combined therapy with carvedilol and aliskiren improve cardiac sympathetic nerve activity, cardiac function, symptoms, exercise capacity, and brain natriuretic peptide in patients with dilated cardiomyopathy?

Population

44 patients with dilated cardiomyopathy (DCM), mean age 62±14 years, 9 women and 35 men. Key inclusion: NYHA class II or III, LVEF ≤45% by quantitative gated SPECT, at least one episode of heart failure requiring short-term hospitalization, and symptomatic at the start of treatment.

Intervention

Carvedilol (initial 1.25-2.5 mg/day, maintenance 10 mg/day) plus aliskiren (150 mg/day) added to basal heart failure medications (diuretics, aldosterone antagonists) for 6 months.

Comparator

Carvedilol alone (initial 1.25-2.5 mg/day, maintenance 10 mg/day) added to basal heart failure medications (diuretics, aldosterone antagonists) for 6 months.

Outcome

Changes in cardiac sympathetic nerve activity (evaluated by 123I-MIBG imaging: delayed heart-to-mediastinum activity ratio [H/M], delayed total defect score [TDS], and washout rate [WR]), cardiac function (LVEF, EDV, ESV), symptoms (NYHA class), exercise capacity (specific activity scale [SAS], peak VO2), and brain natriuretic peptide (BNP) at 6 months.surrogate

The addition of aliskiren to carvedilol in patients with dilated cardiomyopathy significantly improves cardiac sympathetic nerve activity, left ventricular ejection fraction, and clinical symptoms compared to carvedilol alone.

Main Result

p-value: p=<0.05

Abstract

Purpose/Method: Aliskiren is a direct renin inhibitor that has been reported to be effective for CHF, but the usefulness of combined therapy with carvedilol and aliskiren has not been reported. Forty-four patients with dilated cardiomyopathy (DCM) were randomized into a group receiving add-on therapy with carvedilol plus aliskiren and another group receiving carvedilol alone for 6 months.Nuclear imagings with 123I-Metaiodobenzylguanidine (MIBG) and 99mTc-Sestamibi were performed. Exercise capacity using a specific activity scale (SAS) and the New York Heart Association (NYHA) class were evaluated. Cardiac sympathetic nerve activity was evaluated by 123I-MIBG imaging, with the delayed heart-to-mediastinum activity ratio (H/M), delayed total defect score (TDS), and washout rate (WR).Results: Combined add-on therapy with carvedilol and aliskiren improved several parameters much more than carvedilol alone (p<0.05) with respect to TDS, ejection fraction (EF), NYHA, SAS on 6 months and the changes in TDS, EF, end-diastolic volume and brain natriuretic peptide (BNP).Conclusion: Add-on therapy with carvedilol and aliskiren is more effective than carvedilol alone for improving cardiac sympathetic nerve activity, cardiac function, symptoms, exercise capacity, and brain natriuretic peptide in patients with DCM.

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