Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction; Cardiovascular Morbidity

• Registration Number: NCT06208007
• Lead Sponsor: University Medical Center Goettingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Study Start: 2024-02-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2026-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 \[min. 0 points, max. 6 points\]
Composite endpoint cardiovascular events	24 months	Cardiovascular hospitalisation or death
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 \[min. 0 points, max. 6 points\]

Secondary Outcome Measures

Name	Time	Method
Change of blood-creatinine	24 months
Change of NT-proBNP	24 months
Change of individual parameters included in the 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 \[min. 0 points, max. 6 points\]
Change of NYHA-class	24 months
Development or aggravation of albuminuria	24 months

Trial Locations

Locations (1)

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Niedersachsen, Germany