- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emine Tunç Süygün
- Phone Number: +90338 226 21 92
- Email: fzteminetunc@gmail.com
Study Locations
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Karaman, Turkey (Türkiye)
- Recruiting
- Karaman Training and Research Hospital
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Contact:
- Karaman Training and Research Hospital
- Phone Number: +90338 226 30 00
- Email: karaman.eah@saglik.gov.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Association Between the Pre-to-Post Exercise Change in Blood Pressure and Aortic Stiffness
Time Frame: 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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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KMU-TUNCSUYGUN-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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