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Minerva Cardioangiologica 2020 June;68(3):216-23

DOI: 10.23736/S0026-4725.19.05029-1


language: English

Fatigue due to mild heart failure: effects of Robuvit® in a concept, pilot registry study

Gianni BELCARO 1, 2 , Maria R. CESARONE 1, 2, Valeria SCIPIONE 1, 2, Claudia SCIPIONE 1, 2, Mark DUGALL 1, 2, Shu HU 1, 2, Morio HOSOI 1, 2, Roberto COTELLESE 1, 2, Nello OLIVIERI 1, 2, Beatrice FERAGALLI 1, 2, Andrea LEDDA 1, 2

1 Irvine3 labs & PAP/PEA Screening Project and the International Irvine Network, Department SMO Biotec and Cardiology School, G. D’Annunzio University, Chieti-Pescara, Pescara, Italy; 2 The International Agency for Pharma Standard Supplements, Pescara, Italy

BACKGROUND: The aim of this supplement registry study was the evaluation of possible benefits of Robuvit® (oak wood extract) as a standardized supplement (in an 8-week registry) in stable, mild, heart failure patients.
METHODS: All subjects received the standard management (SM) for this condition. Otherwise healthy subjects with mild, initial symptoms (mild shortness of breath and/or angina) and slight limitation during their normal daily activity were included. This corresponds to the New York Heart Association (NYHA) Functional Classification class II.
RESULTS: Forty subjects were included in the study. The two groups completing 8 weeks were comparable at baseline with 20 subjects managed with SM and 20 subjects supplemented with Robuvit® in addition to SM. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). The age and symptoms of the supplemented patients and the controls were comparable at baseline. There were no dropouts. At 8 weeks, systolic-diastolic pressure, heart rate, respiratory rate were minimally (non-significantly) lowered with the supplement without differences in controls. Ultrasound-derived ejection fraction was significantly increased in the supplement group (P<0.05) while there were minimal, non-significant differences in controls. Walking distance on treadmill was also significantly increased in the supplement group (P<0.05) and significantly less in controls. The microcirculation (laser Doppler parameters and transcutaneous PO2, PCO2) improved significantly in the Robuvit® group (P<0.05) in comparison with the non-supplemented controls. Oxidative stress was significantly decreased (P<0.05) with the supplement while there were minimal, non-significant changes in controls.
CONCLUSIONS: In conclusion in this pilot, supplement registry Robuvit® seems to help and improve patients with mild heart failure and should be considered for larger studies.

KEY WORDS: Fatigue; Heart failure; Robuvit; Cardiac output; Chronic disease; Ventricular function, left

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