Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

NCT ID: NCT06208007

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-23

Study Completion Date

2028-01-31

Brief Summary

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Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.

Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction Cardiovascular Morbidity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

One or more of the following criteria:

* Age \> 60 years
* Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
* Diabetes mellitus Type I or II
* Atrial fibrillation
* Chronic kidney disease (GFR \< 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
* BMI ≥ 30 kg/m2
* NYHA ≥ II
* E/e' \> 8

Exclusion Criteria

* Left ventricular ejection fraction \< 50 %
* Significant valve disease (Grade III or higher)
* History of interventional or surgical valve repair
* Regional wall motion abnormalities
* Respiratory diseases as a known cause for dyspnea
* Atrial flutter or fibrillation during examination
* Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy
* History of heart transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Alexander Schulz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Alexander Schulz, Dr. med.

Role: primary

0049 551 3967601

Other Identifiers

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9/12/23

Identifier Type: -

Identifier Source: org_study_id

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