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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06208007
Other study ID # 9/12/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2024
Est. completion date January 2028

Study information

Verified date May 2024
Source University Medical Center Goettingen
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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