NCT07737561

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 15, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association Between the Pre-to-Post Exercise Change in Blood Pressure and Aortic Stiffness

    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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 18 years and older with a diagnosis of Cardiovascular-Kidney-Metabolic (CKM) syndrome who are referred to the cardiology outpatient clinic and scheduled for a clinically indicated exercise stress test as part of routine clinical care.

You may qualify if:

  • 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.

You may not qualify if:

  • Physical disability or any medical condition that precludes performing an exercise stress test.
  • Diagnosis of major depressive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Ndumele CE, Rangaswami J, Chow SL, Neeland IJ, Tuttle KR, Khan SS, Coresh J, Mathew RO, Baker-Smith CM, Carnethon MR, Despres JP, Ho JE, Joseph JJ, Kernan WN, Khera A, Kosiborod MN, Lekavich CL, Lewis EF, Lo KB, Ozkan B, Palaniappan LP, Patel SS, Pencina MJ, Powell-Wiley TM, Sperling LS, Virani SS, Wright JT, Rajgopal Singh R, Elkind MSV; American Heart Association. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation. 2023 Nov 14;148(20):1606-1635. doi: 10.1161/CIR.0000000000001184. Epub 2023 Oct 9.

    PMID: 37807924BACKGROUND

Central Study Contacts

Emine Tunç Süygün

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations