ACRPPAmbulatory 24-Hour Cardiac Oxygen Consumption and Blood Pressure-Heart Rate Variability: Effects of Nebivolol and Valsartan Alone and in Combination
Nebivolol
+ Valsartan
+ Nebivolol/valsartan combination
Maladies Cardiovasculaires
+ Hypertension
+ Maladies vasculaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2013
Date à laquelle le premier participant a commencé l'étude.Subjects with hypertension (systolic blood pressure (SBP) >140 or diastolic blood pressure (DBP)>90, n=26) were studied using a double-blinded, forced-titration, sequence-controlled, crossover design with 3 experimental periods: Valsartan 320, nebivolol 40, and nebivolol/valsartan 320/40 mg daily. After 4 weeks of each drug, ambulatory pulse wave analysis (IEM MobilOGraph) was performed every 20 min for 24-hours. The primary hypothesis was that nebivolol/valsartan combination therapy would be superior to valsartan monotherapy in reducing mean 24-hour mean myocardial oxygen consumption determined by 24-hour ambulatory heart rate-central systolic pressure product \[ACRPP\]. A secondary hypothesis was that the combination would also reduce the variability of 24-hour myocardial oxygen consumption.
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.26 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 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Subjects with chronic hypertension, treated or untreated * Males and females, 18 years or older * Seated clinic systolic BP 145-184 mmHg inclusive or * Seated clinic diastolic BP 92-119 mmHg, inclusive. Exclusion Criteria: * Subjects with any of the following conditions will be excluded: * Any acute or chronic medical condition that, in the judgment of the investigator, renders the subject unable to complete the study, would interfere with optimal participation in the study, or cause significant risk to the subject * Concomitant or probable need for treatment with other cardiovascular or antihypertensive drugs that may affect blood pressure or influence the effects of study drugs, (e.g. NSAIDs, beta-agonist inhalers therapy for bronchospastic asthma, diuretics); other stable chronic medications that have little effect on study drugs (e.g. diabetes medications, hormone replacements, chronic pain medications. osteoporosis drugs, vitamins, cholesterol drugs, etc.) are permitted if continued at stable doses throughout study. * History of clinically significant adverse events with beta-blocker or angiotensin-receptor blocker * Known or suspected secondary hypertension (e.g., renovascular hypertension, primary hyperaldosteronism, etc.) * Known ischemic heart disease requiring continuous beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry). * Dilated cardiomyopathy (NYHA Functional Class III-IV) * Clinically significant valvular heart disease or obstructive hypertrophic cardiomyopathy * Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree atrioventricular block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome. * Chronic kidney disease (serum creatinine \>2.5 mg/dL) * Uncontrolled diabetes mellitus (hemoglobin A1c \> 10%) * History of alcohol or other drug abuse within 6 months prior to enrollment * Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.6 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifGroupe III
Comparateur actifGroupe IV
Comparateur actifGroupe 5
Comparateur actifGroupe 6
Comparateur actifObjectifs 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