Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure

4 février 2019 mis à jour par: University of Wisconsin, Madison
Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for older persons with heart failure (HF). Little is known about the relationship between brain MRI and cognitive impairment in older persons with HF. A limited number of studies have investigated brain MRI in adults with HF and produced conflicting results. Previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences) and recruitment of mixed age samples. Based on these limitations, the purpose of this research plan is to explore the relationship between brain MRI and cognitive impairment in older persons with HF using high resolution structural and perfusion scans. To accomplish this goal, investigators will compare 40 adults with HF who are age > 65 years old with 40 healthy, gender, age, and education matched controls. Investigators will obtain neuropsychological measures of multiple domains, as well as MRI measurements of the temporal lobe and prefrontal cortex at baseline and 12-months.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for persons > 65 years old with HF. Although the degree of cognitive impairment usually does not meet the criteria for dementia, it can affect an individual's ability to process and remember information, such as complex medication regimens [5]. Findings suggest that brain regions that support memory (i.e. temporal lobe) and executive function (i.e. prefrontal cortex) may be altered in older persons with HF; suggesting that these brain alterations are related to the HF disease process and not normal aging. Surprisingly, despite the high prevalence of cognitive impairment in HF, relationships between brain and cognition have not been well studied.

Little is known about the relationships between brain magnetic resonance imaging (MRI) and cognitive impairment in older persons with HF. A limited number of studies have investigated brain MRI in adults with HF and produced conflicting results. Three studies utilized structural MRI techniques and identified evidence of atrophy in the temporal lobe, hippocampus, and prefrontal cortex and an increased volume of white matter hyperintensities [6-8]. Brain hypoperfusion, operationalized as decreased global cerebral perfusion, was identified in two studies [9, 10]. Only one study examined relationships between brain MRI and cognitive impairment in HF [6]. Vogels et al., (2007) found that atrophy in the medial temporal lobe was associated with decreased measures of memory and executive function. White matter hyperintensities did not correlate with any cognitive measures. Limited research findings indicate that various brain alterations in the temporal lobe, hippocampus, and prefrontal cortex contribute to cognitive impairment in HF. However, previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. structural and perfusion scans) and recruitment of mixed age samples.

Based on these limitations, the purpose of this research plan is to explore relationships between brain MRI and cognitive impairment in older persons with HF using high resolution structural and perfusion scans. To accomplish this goal, investigators will compare 40 adults with HF who are > 65 years old with 40 healthy, gender, age, and education matched controls. Investigators will obtain neuropsychological measures of multiple domains, as well as MRI measurements of the temporal lobe and prefrontal cortex at baseline and 12-months. The following specific aims will be investigated:

Aim 1: Compare brain MRI in older persons with HF and controls at baseline and 12-months.

Hypothesis 1a: Older persons with HF will have increased white matter hyperintensities, decreased grey matter volume, and decreased perfusion in the temporal lobe and prefrontal cortex compared with controls. Hypothesis 1b: Older persons with HF will exhibit a greater decline in grey matter volume in the temporal lobe and prefrontal cortex over 12-months compared with controls.

Aim 2: Compare cognitive function in older persons with HF and controls at baseline and 12-months.

Hypothesis 2a): Older persons with HF will perform lower on measures of memory and executive function compared with controls.

Hypothesis 2b): Older persons with HF will exhibit a greater decline on measures of memory and executive function over 12-months compared with controls.

Aim 3: Examine the relationships between brain MRI and cognitive function in older persons with HF and controls at baseline.

Hypothesis 3a: Decreased grey matter and perfusion in the temporal lobe and an increased volume of white matter hyperintensities in the temporal lobe will be associated with decreased memory scores.

Hypothesis 3b: Decreased grey matter and perfusion in the prefrontal cortex and an increased volume of white matter hyperintensities in the prefrontal cortex will be associated with a decreased executive function score.

Type d'étude

Observationnel

Inscription (Réel)

40

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53792
        • University of Wisconsin Hospital and Clinics

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 85 ans (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Older adults with heart failure

La description

Inclusion Criteria:

  • 65 years old or older
  • English speaking and writing;
  • Stable guideline based medication regimen for at least four weeks prior to enrollment
  • New York Heart Association classification I-IV

Exclusion Criteria:

  • Mini-Mental Status Exam score equal to or less than 24;
  • Current diagnosis of neurological illnesses or movement disorders (e.g. Alzheimer's dementia, Parkinson's disease, Epilepsy);
  • History of substance abuse/treatment;
  • Untreated depression
  • History of stroke;
  • Hepatic insufficiency;
  • Severe renal failure;
  • Untreated anemia;
  • Left ventricular assist device;
  • History of the following within three months of study enrollment: acute myocardial infarction, unstable angina, coronary artery bypass surgery, percutaneous transluminal angioplasty, or biventricular pacemaker insertion;
  • History of implantable device (or other MRI contraindications).
  • Prisoners
  • Pregnancy

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Older adults with heart failure

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean neuropsychological test scores and brain changes
Délai: One year

Compare mean values of the following outcomes between older adults with heart failure and older adults without heart failure at baseline

  • neuropsychological test scores
  • brain medial temporal lobe volume
  • brain frontal cortex volume
  • brain medial temporal lobe perfusion
  • brain frontal cortex perfusion

Compare mean value changes in the following outcomes between baseline and one year in patients with heart failure:

  • neuropsychological test scores
  • brain medial temporal lobe volume
  • brain frontal cortex volume
  • brain medial temporal lobe perfusion
  • brain frontal cortex perfusion
One year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Lisa C Bratzke, PhD, University of Wisconsin, Madison

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2013

Achèvement primaire (Réel)

31 décembre 2017

Achèvement de l'étude (Réel)

31 décembre 2018

Dates d'inscription aux études

Première soumission

20 mars 2013

Première soumission répondant aux critères de contrôle qualité

26 mars 2013

Première publication (Estimation)

1 avril 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 février 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 février 2019

Dernière vérification

1 février 2019

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Insuffisance cardiaque

3
S'abonner