Melatonin Replacement Therapy in Pinealectomized Patients

Summary

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.

Timeline

Start

2017-05-02

Primary completion

2018-11-30

Completion

2019-02-28

Publications

• Background Cipolla-Neto J, Amaral FGD. Melatonin as a Hormone: New Physiological and Clinical Insights. Endocr Rev. 2018 Dec 1;39(6):990-1028. doi: 10.1210/er.2018-00084.
• Background Baltatu OC, Amaral FG, Campos LA, Cipolla-Neto J. Melatonin, mitochondria and hypertension. Cell Mol Life Sci. 2017 Nov;74(21):3955-3964. doi: 10.1007/s00018-017-2613-y. Epub 2017 Aug 8.
• Background Campos LA, Cipolla-Neto J, Michelini LC. Melatonin modulates baroreflex control via area postrema. Brain Behav. 2013 Mar;3(2):171-7. doi: 10.1002/brb3.123. Epub 2013 Feb 17.
• Background Pereira VL Jr, Dobre M, Dos Santos SG, Fuzatti JS, Oliveira CR, Campos LA, Brateanu A, Baltatu OC. Association between Carotid Intima Media Thickness and Heart Rate Variability in Adults at Increased Cardiovascular Risk. Front Physiol. 2017 Apr 26;8:248. doi: 10.3389/fphys.2017.00248. eCollection 2017.
• Background Campos LA, Pereira VL Jr, Muralikrishna A, Albarwani S, Bras S, Gouveia S. Mathematical biomarkers for the autonomic regulation of cardiovascular system. Front Physiol. 2013 Oct 7;4:279. doi: 10.3389/fphys.2013.00279.
• Background Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
• Campos LA, Bueno C, Barcelos IP, Halpern B, Brito LC, Amaral FG, Baltatu OC, Cipolla-Neto J. Melatonin Therapy Improves Cardiac Autonomic Modulation in Pinealectomized Patients. Front Endocrinol (Lausanne). 2020 Apr 30;11:239. doi: 10.3389/fendo.2020.00239. eCollection 2020.

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Indications