ONTx+HFAmélioration de la fonction musculaire squelettique chez les patients âgés atteints d'insuffisance cardiaque par thérapie orale à base de nitrite
Cette étude de phase 2 vise à évaluer l'efficacité de la thérapie par nitrite oral pour améliorer la fonction musculaire squelettique chez les patients âgés souffrant d'insuffisance cardiaque, en évaluant la fonction mitochondriale et l'expression des gènes pertinents par le biais d'une biopsie musculaire squelettique.
14 N Sodium Nitrite
Maladies Cardiovasculaires
+ Maladies Cardiaques
+ Insuffisance cardiaque
Étude thérapeutique
Résumé
Date de début de l'étude : 8 janvier 2016
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.21 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site