- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Emine Tunç Süygün
- Telefonní číslo: +90338 226 21 92
- E-mail: fzteminetunc@gmail.com
Studijní místa
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Karaman, Turecko (Türkiye)
- Nábor
- Karaman Training and Research Hospital
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Kontakt:
- Karaman Training and Research Hospital
- Telefonní číslo: +90338 226 30 00
- E-mail: karaman.eah@saglik.gov.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Association Between the Pre-to-Post Exercise Change in Blood Pressure and Aortic Stiffness
Časové okno: During a single study visit: immediately before and immediately after the exercise stress test
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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.
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During a single study visit: immediately before and immediately after the exercise stress test
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- KMU-TUNCSUYGUN-004
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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