Clinical Trials Logo

Clinical Trial Summary

The objective of this project is to determine if Neo40, a nitric oxide generating lozenge, when consumed twice daily by subjects with HFpEF, will increase exercise tolerance, decrease symptoms and improve quality of life for patients.


Clinical Trial Description

Heart failure (HF) is the most common principal diagnosis for hospital admission in patients over 65 years old. There are two types of HF, those with reduced ejection fraction (HFrEF) and those with preserved ejection fraction (HFpEF). Approximately half of patients with the clinical syndrome of HF have preserved systolic function. HEpEF is becoming more prevalent with aging of the population and obesity. There are only two class I recommendations for the treatment of HFpEF, which are controlling blood pressure and the use of diuretics to relieve symptoms. Exercise training is another approach to improving symptoms, however it may be poorly tolerated. Nitrate supplement in the form of concentrated beetroot juice was recently shown to improve exercise tolerance in patients with HFpEF. (1) Beetroot juice contains high concentration of nitrate (NO3). This is metabolized to nitrite (NO2). It enters the blood stream, where it is further reduced to nitric oxide (NO) resulting in intense vasodilation. Patients with diastolic dysfunction are often asymptomatic at rest but complain of dyspnea with exertion. Increase in heart rate with exercise causes reduced diastolic filling time and increases left sided filling pressure. Borloug, et al demonstrated this with right heart catheterization and supine exercise in patients with diastolic dysfunction. Infusion of NO2 resulted in decreased filling pressures and increased cardiac output. (2) Neo40 is a new product made from concentrated beetroot juice in the form of a lozenge designed to dissolve on the tongue. NO3 supplement causes vasodilatation only in the setting of hypoxia and acidosis resulting in targeted vasodilatation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03289481
Study type Interventional
Source MaineHealth
Contact
Status Completed
Phase Early Phase 1
Start date June 29, 2017
Completion date August 22, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT02173548 - Interleukin-1 Blockade in HF With Preserved EF Phase 2
Completed NCT02459626 - Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction
Completed NCT03310099 - Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients N/A
Completed NCT02638961 - Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF N/A
Completed NCT03871803 - β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR) Phase 4
Completed NCT03672591 - Renal Hemodynamics in Patients With HFpEF
Recruiting NCT03620526 - Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction Phase 4
Active, not recruiting NCT03624010 - Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients Phase 2
Completed NCT03541603 - Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF Phase 2
Completed NCT03141567 - LYmphangiogenesis FacTors in Heart Failure States
Completed NCT02744339 - Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction Phase 2
Completed NCT03387813 - Hemodynamic-GUIDEd Management of Heart Failure N/A
Completed NCT03186833 - The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
Terminated NCT03195660 - Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study N/A
Completed NCT03226652 - Heart Function in Patients Assessed for Sleep Apnoea
Completed NCT03966755 - Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF N/A
Not yet recruiting NCT04282850 - Ablation Versus Medical Management of Atrial Fibrillation in HFpEF N/A
Recruiting NCT03184311 - High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction N/A
Withdrawn NCT03317314 - Cardiopulmonary Interactions in Patients With Heart Failure