Heart Failure With Normal Ejection Fraction Clinical Trial
Official title:
Treatment of HFpEF With Nitrate Supplement: A Double-blind, Placebo Controlled Trial Including Patients With Atrial Fibrillation
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT02459626 -
Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction
|
||
Completed |
NCT02173548 -
Interleukin-1 Blockade in HF With Preserved EF
|
Phase 2 | |
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
|