Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Left ventricular ejection fraction < 50 %
Significant valve disease (Grade III or higher)
History of interventional or surgical valve repair
Regional wall motion abnormalities
Trial population
Patients at risk for HFpEF
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change 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 \[min. 0 points, max. 6 points\]
Time frame
24 months2
Development of HFpEF
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 \[min. 0 points, max. 6 points\]
Time frame
24 months3
Composite endpoint cardiovascular events
Cardiovascular hospitalisation or death
Time frame
24 monthsSecondary outcomes
1
Change of individual parameters included in the 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 \[min. 0 points, max. 6 points\]
Time frame
24 months2
Change of NT-proBNP
Time frame
24 months3
Change of NYHA-class
Time frame
24 months4
Development or aggravation of albuminuria
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov