PMID- 32586072 OWN - NLM STAT- MEDLINE DCOM- 20210428 LR - 20210428 IS - 1827-1618 (Electronic) IS - 0026-4725 (Linking) VI - 68 IP - 3 DP - 2020 Jun TI - Fatigue due to mild heart failure: effects of Robuvit(R) in a concept, pilot registry study. PG - 216-223 LID - 10.23736/S0026-4725.19.05029-1 [doi] AB - BACKGROUND: The aim of this supplement registry study was the evaluation of possible benefits of Robuvit(R) (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(R) 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(R) 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(R) seems to help and improve patients with mild heart failure and should be considered for larger studies. FAU - Belcaro, Gianni AU - Belcaro G AD - 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 - cardres@abol.it. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy - cardres@abol.it. FAU - Cesarone, Maria R AU - Cesarone MR AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Scipione, Valeria AU - Scipione V AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Scipione, Claudia AU - Scipione C AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Dugall, Mark AU - Dugall M AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Hu, Shu AU - Hu S AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Hosoi, Morio AU - Hosoi M AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Cotellese, Roberto AU - Cotellese R AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Olivieri, Nello AU - Olivieri N AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Feragalli, Beatrice AU - Feragalli B AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. FAU - Ledda, Andrea AU - Ledda A AD - 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. AD - The International Agency for Pharma Standard Supplements, Pescara, Italy. LA - eng PT - Journal Article PL - Italy TA - Minerva Cardioangiol JT - Minerva cardioangiologica JID - 0400725 RN - 0 (Hydrolyzable Tannins) RN - 0 (Plant Extracts) RN - 0 (Robuvit) SB - IM MH - Dietary Supplements MH - Exercise Test MH - Fatigue/*drug therapy/etiology MH - Heart Failure/complications/*drug therapy MH - Humans MH - Hydrolyzable Tannins/*administration & dosage MH - Male MH - Microcirculation/drug effects MH - Middle Aged MH - Oxidative Stress/drug effects MH - Pilot Projects MH - Plant Extracts/*administration & dosage MH - Registries MH - Stroke Volume/drug effects EDAT- 2020/06/27 06:00 MHDA- 2021/04/29 06:00 CRDT- 2020/06/27 06:00 PHST- 2020/06/27 06:00 [entrez] PHST- 2020/06/27 06:00 [pubmed] PHST- 2021/04/29 06:00 [medline] AID - S0026-4725.19.05029-1 [pii] AID - 10.23736/S0026-4725.19.05029-1 [doi] PST - ppublish SO - Minerva Cardioangiol. 2020 Jun;68(3):216-223. doi: 10.23736/S0026-4725.19.05029-1.