Heart Failure — Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure
Citation(s)
Al-Zaiti SS, Pietrasik G, Carey MG, Alhamaydeh M, Canty JM, Fallavollita JA The role of heart rate variability, heart rate turbulence, and deceleration capacity in predicting cause-specific mortality in chronic heart failure. J Electrocardiol. 2019 Jan-Feb;52:70-74. doi: 10.1016/j.jelectrocard.2018.11.006. Epub 2018 Nov 6.
Auricchio A, Gold MR, Brugada J, Nolker G, Arunasalam S, Leclercq C, Defaye P, Calo L, Baumann O, Leyva F Long-term effectiveness of the combined minute ventilation and patient activity sensors as predictor of heart failure events in patients treated with cardiac resynchronization therapy: Results of the Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT device Trial (CLEPSYDRA) study. Eur J Heart Fail. 2014 Jun;16(6):663-70. doi: 10.1002/ejhf.79. Epub 2014 Mar 17.
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.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
