Mayo Clinic proceedings
-
Mayo Clinic proceedings · Feb 2024
Randomized Controlled Trial Multicenter StudyInorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction: The INABLE-Training Trial.
To determine whether nitrite can enhance exercise training (ET) effects in heart failure with preserved ejection fraction (HFpEF). ⋯ For patients with HFpEF, ET administered for 12 weeks in a predominantly rural setting improved exercise capacity and health status, but compared with placebo, treatment with inorganic nitrite did not enhance the benefit from ET.
-
Mayo Clinic proceedings · Feb 2024
ReviewClinical Trials for Special Populations: Children, Older Adults, and Rare Diseases.
Research cannot maximize population health unless it improves health for all members of the public, including special populations such as children, older adults, and people living with rare diseases. Each of these categories require special considerations when planning and performing clinical trials, and common threads of ethical conduct of research in vulnerable populations appear throughout. In this review, definitions of each of the three categories of special population (children, older adults, and rare diseases) are discussed in terms of US research regulations, the unique challenges to conducting clinical trials for these special populations, critical ethical issues, and opportunities for innovative ways to design and operationalize clinical trials in special populations. Additional critical attention is focused on factors that influence the generalizability of study results to reduce health disparities, as well as the importance of community engagement and advocacy groups that can help to educate potential trial participants of the benefits of clinical trial participation.