Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

— ARTSPREDICTION  

Official title:

Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208007
• Other study ID #: 9/12/23
• Status: Recruiting
• Start date: March 2024
• Est. completion date: January 2028

Study information

• Verified date: February 2024
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Morbidity
• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	24 months
Primary	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]	24 months
Primary	Composite endpoint cardiovascular events	Cardiovascular hospitalisation or death	24 months
Secondary	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]	24 months
Secondary	Change of NT-proBNP		24 months
Secondary	Change of NYHA-class		24 months
Secondary	Development or aggravation of albuminuria		24 months
Secondary	Change of blood-creatinine		24 months