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Clinical Trials in Germany / NCT06208007
Recruiting Observational

Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

NCT06208007 · tracked via the Priya Life Science Germany tracker
Sponsor
University Medical Center Goettingen
Phase
Observational
Started
2024-02-23
Last updated
2024-05-09

Condition(s) studied

Heart Failure With Preserved Ejection FractionCardiovascular Morbidity

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in HFA-PEFF-Score — 24 months
    Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF \[min. 0 points, max. 6 points\]
  • Development of HFpEF — 24 months
    Defined as ≥ 5 points in HFA-PEFF-Score Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF \[min. 0 points, max. 6 points\]
  • Composite endpoint cardiovascular events — 24 months
    Cardiovascular hospitalisation or death

Trial sites (1)

FacilityCityRegionStatus
Universitätsmedizin Göttingen Göttingen Lower Saxony Recruiting

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Other trials for the same condition

CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction Recruiting
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) Active, not recruiting
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting
Managing Congestion in Heart Failure: A Mechanistic Study in Patients With HFpEF Recruiting
"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06208007 on ClinicalTrials.gov ↗ ← All trials in Germany