Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- University Medical Center Goettingen
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Composite endpoint cardiovascular events
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Alexander Schulz
Principal Investigator
University Medical Center Goettingen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Composite endpoint cardiovascular events
Time Frame: 24 months
Cardiovascular hospitalisation or death
Change in HFA-PEFF-Score
Time Frame: 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
Time Frame: 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 Outcomes
- Development or aggravation of albuminuria(24 months)
- Change of blood-creatinine(24 months)
- Change of NT-proBNP(24 months)
- Change of individual parameters included in the HFA-PEFF-Score(24 months)
- Change of NYHA-class(24 months)