ONTx+HFMejoramiento de la Función Muscular Esquelética en Pacientes Ancianos con Insuficiencia Cardíaca mediante Terapia Oral con Nitritos
Este estudio de fase 2 tiene como objetivo evaluar la eficacia de la terapia con nitrito oral para mejorar la función muscular esquelética en pacientes ancianos con insuficiencia cardíaca, mediante la evaluación de la función mitocondrial y la expresión de genes pertinentes a través de una biopsia muscular esquelética.
14 N Sodium Nitrite
Enfermedades Cardiovasculares
+ Enfermedades del Corazón
+ Insuficiencia Cardíaca
Estudio de Tratamiento
Resumen
Fecha de inicio: 8 de enero de 2016
Fecha en la que se inscribió al primer participante.Heart failure (HF) is a common condition in older adults, with its prevalence increasing as the population ages. This study focuses on older heart failure patients, specifically those with HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). The goal is to investigate the benefits of nitrite therapy, in addition to standard HF care, to improve physical function. This is important because heart failure often leads to muscle weakness and exercise intolerance, which are worsened by aging. The study aims to understand if daily nitrite supplements can improve aerobic and strength indices, as well as underlying skeletal muscle mechanisms. During the study, participants will take daily nitrite supplements. The effects of these supplements on skeletal muscle performance and physical function will be measured. This includes assessing maximal and submaximal aerobic and strength indices, skeletal muscle mitochondrial performance, gene expression, and capillarity. The study also aims to show that improved skeletal muscle metabolism is associated with shifts in anabolic gene expression and reduced catabolic gene expression and inflammation. The ultimate goal is to demonstrate that oral nitrite supplements can increase the efficiency of work, requiring less oxygen for the same work intensity.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 21 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Inclusion Criteria HF Population * New York Heart Association (NYHA) class II or III for the previous three months despite a minimum of 6 weeks of treatment. Echo criteria will be confirmed as part of the initial study assessment. * Age ≥70 years * HFrEF patients left ventricular ejection fraction (LVEF) ≤40% * HFpEF patients LVEF\>40%, may include E/E' \>8, left atrial size\>40 mL/m2 * Optimal therapy according to American Heart Association (AHA)/American College of Cardiology(ACC) and Heart Failure Society of America (HFSa) HFrEF guidelines, including treatment with angiotensin-converting enzyme inhibitor (ACEI) and beta-blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment. * Patients using aspirin (ASA) will be eligible, but asked to hold the medication for 48 hours prior to biopsy. This technique has previously been used with consistent safety. Patients will also be asked to avoid non-steroidal anti-inflammatory medications (NSAIDs) for 48 hours prior to the biopsy. * Patients using anti-thrombin and anti-platelet therapy will plan to modify prior to muscle biopsies individually in coordination with the participant's primary cardiologist. Inclusion Criteria Age-Matched Control Population * Age ≥70 years * Absence of any type of cardiovascular disease. * Absence of diabetes or other chronic disease processes Exclusion Criteria: Exclusion Criteria for All participants * Allergy to lidocaine * Dementia * End-stage malignancy * Orthopedic exercise limitation * Chronic use of oral corticosteroids or other medications that affect muscle function. * Chronic ethyl alcohol (ETOH) or drug dependency. * Any bleeding disorder that would contraindicate biopsy such as history of clinically significant bleeding diathesis (e.g., Hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency). * Psychiatric hospitalization within the last 3 months Exclusion Criteria HF Population * Major cardiovascular event or procedure within the prior 6 weeks. * HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, patient may not be enrolled for 12 months after this procedure. * Severe valvular heart disease * Mechanical valve replacement requiring warfarin * Currently taking clopidogrel for a recent stent placement and/or a complex atherosclerotic lesion such that holding clopidogrel creates disproportionate risk. * ICD (Internal cardiodefibrillator) device with heart rate limits that prohibit exercise assessments. Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación