Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

NCT06208007 | Recruiting

• 1 other identifier: 9/12/23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Cardiovascular Morbidity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Composite endpoint cardiovascular events

  Cardiovascular hospitalisation or death

  24 months

Secondary Outcomes (5)

• Change of individual parameters included in the HFA-PEFF-Score

  24 months

• Change of NT-proBNP

  24 months

• Change of NYHA-class

  24 months

• Development or aggravation of albuminuria

  24 months

• Change of blood-creatinine

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at risk for HFpEF

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples, urine samples

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: February 23, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

DE (1)