- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07737561
Blood Pressure Response to Exercise and Aortic Stiffness in Patients With Cardiovascular-Kidney-Metabolic Syndrome
The Relationship Between Blood Pressure Response to Exercise Testing and Aortic Stiffness in Patients With Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-Kidney-Metabolic (CKM) syndrome is a recently defined clinical syndrome characterized by the coexistence and interaction of cardiovascular disease, chronic kidney disease, and metabolic disorders, including obesity, dyslipidemia, insulin resistance, and type 2 diabetes mellitus. Individuals with CKM syndrome commonly exhibit vascular dysfunction, endothelial impairment, arterial stiffness, and an increased risk of cardiovascular morbidity and mortality. Although exaggerated blood pressure response during exercise has been recognized as an early marker of future hypertension and adverse cardiovascular outcomes, its relationship with aortic stiffness in patients with CKM syndrome has not been adequately investigated.
The aim of this observational study is to evaluate the association between blood pressure response during a clinically indicated exercise stress test and aortic stiffness in adults with CKM syndrome. Eighty patients with physician-diagnosed CKM syndrome who are referred for routine exercise stress testing in the cardiology outpatient clinic will be enrolled. Blood pressure will be measured immediately before and after the exercise test. Aortic stiffness will be assessed using transthoracic echocardiography by calculating the aortic stiffness index (β-index) from systolic and diastolic aortic diameters and concurrent blood pressure measurements. Demographic characteristics, anthropometric measurements, cardiovascular risk factors, medication use, lifestyle characteristics, and clinical data will also be collected. The findings may clarify whether blood pressure response during routine exercise testing can serve as a simple, non-invasive indicator of increased aortic stiffness and improve cardiovascular risk stratification in individuals with CKM syndrome.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emine Tunç Süygün
- Numéro de téléphone: +90338 226 21 92
- E-mail: fzteminetunc@gmail.com
Lieux d'étude
-
-
-
Karaman, Turquie (Türkiye)
- Recrutement
- Karaman Training and Research Hospital
-
Contact:
- Karaman Training and Research Hospital
- Numéro de téléphone: +90338 226 30 00
- E-mail: karaman.eah@saglik.gov.tr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Willing and able to provide written informed consent.
- Aged 18 years or older.
- Diagnosis of Cardiovascular-Kidney-Metabolic (CKM) syndrome.
- Referred by a cardiologist for a clinically indicated exercise stress test as part of routine clinical care.
- Able to perform an exercise stress test.
Exclusion Criteria:
- Physical disability or any medical condition that precludes performing an exercise stress test.
- Diagnosis of major depressive disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Patients With Cardiovascular-Kidney-Metabolic Syndrome
Adults diagnosed with Cardiovascular-Kidney-Metabolic (CKM) syndrome who are referred by a cardiologist for a clinically indicated exercise stress test as part of routine care.
Participants undergo routine exercise stress testing and transthoracic echocardiography for assessment of aortic stiffness.
Blood pressure response during exercise and aortic stiffness parameters are evaluated to investigate their association.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Association Between the Pre-to-Post Exercise Change in Blood Pressure and Aortic Stiffness
Délai: During a single study visit: immediately before and immediately after the exercise stress test
|
The association between the change in blood pressure from immediately before to immediately after a clinically indicated exercise stress test and the aortic stiffness index (β-index) will be evaluated in adults with Cardiovascular-Kidney-Metabolic syndrome.
Systolic and diastolic blood pressure will be measured immediately before and immediately after the exercise test.
Aortic stiffness will be calculated using systolic and diastolic aortic diameters obtained by transthoracic echocardiography together with concurrent blood pressure measurements.
|
During a single study visit: immediately before and immediately after the exercise stress test
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- KMU-TUNCSUYGUN-004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .