Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jul-Sep;14(3):331-340.
doi: 10.4103/apc.APC_94_21. Epub 2021 Aug 11.

Efficacy and safety of propranolol in infants with heart failure due to moderate-to-large ventricular septal defect (VSD-PHF study) - A prospective randomized trial

Sivasubramanian Ramakrishnan  1 , Nirmal Ghati  2 , Ramandeep Singh Ahuja  3 , Kinjal Niranjan Bhatt  4 , Hem Chandra Sati  5 , Anita Saxena  1 , Shyam Sunder Kothari  1
Affiliations

Efficacy and safety of propranolol in infants with heart failure due to moderate-to-large ventricular septal defect (VSD-PHF study) - A prospective randomized trial

Sivasubramanian Ramakrishnan et al. Ann Pediatr Cardiol. 2021 Jul-Sep.

Abstract

Aims: The utility of beta-blocker therapy in infants with heart failure (HF) due to significant left-to-right shunt lesions is not known. The study aimed to assess the efficacy and safety of propranolol in infants with HF due to moderate-to-large ventricular septal defect (VSD).

Methods: The prospective randomized trial included 80 infants with HF and moderate-to-large VSD, randomly allocated to receive either conventional therapy alone (n = 40) or propranolol plus conventional therapy (n = 40). The primary endpoint was a composite of all-cause mortality, hospitalization for HF and/or chest infection, and referral for surgery. The secondary clinical outcomes were the individual components of the composite endpoint. In addition, the patients were followed up to detect safety outcomes, for example, bronchospasm, bradyarrhythmia, and worsening HF symptoms.

Results: The addition of propranolol therapy to the conventional medications did not result in significant improvement in the primary composite endpoint (32.50% vs. 52.50%; P = 0.07). There was a trend toward improvement, but the study is underpowered for this important question. However, propranolol therapy significantly decreased the risk of hospitalization (12.50% vs. 32.50%; P = 0.03) and worsening of Ross HF class (5.41% vs. 28.21%; P = 0.01) as compared to conventional therapy (estimated number needed to treat = 5). Propranolol did not result in any significant safety concerns in these infants except bronchospasm in an infant.

Conclusions: Propranolol therapy in infants with significant left-to-right shunt may prevent worsening in HF symptoms and hospitalization and is well tolerated. However, it does not reduce mortality or need for surgery.

Keywords: Beta-blocker; left-to-right shunt; pediatric heart failure; propranolol; ventricular septal defect.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Trial consort diagram showing recruitment, randomization, and analysis of the study population. PAH: Pulmonary artery hypertension, ITT: Intention-to-treat, PP: Per-protocol
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Moe DG, Guntheroth WG. Spontaneous closure of uncomplicated ventricular septal defect. Am J Cardiol. 1987;60:674–8. - PubMed
    1. Hsu DT, Zak V, Mahony L, Sleeper LA, Atz AM, Levine JC, et al. Enalapril in infants with single ventricle: Results of a multicenter randomized trial. Circulation. 2010;122:333–40. - PMC - PubMed
    1. Jain S, Vaidyanathan B. Digoxin in management of heart failure in children: Should it be continued or relegated to the history books? Ann Pediatr Cardiol. 2009;2:149–52. - PMC - PubMed
    1. Castro Díez C, Khalil F, Schwender H, Dalinghaus M, Jovanovic I, Makowski N, et al. Pharmacotherapeutic management of paediatric heart failure and ACE-I use patterns: A European survey. BMJ Paediatr Open. 2019;3:e000365. - PMC - PubMed
    1. Leversha AM, Wilson NJ, Clarkson PM, Calder AL, Ramage MC, Neutze JM. Efficacy and dosage of enalapril in congenital and acquired heart disease. Arch Dis Child. 1994;70:35–9. - PMC - PubMed