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NCT Number: NCT06208007

Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location status: Recruiting

Location contact

Alexander Schulz, Dr. med.

CONTACT

[email protected]

0049 551 3967601

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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]

  2. 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]

  3. Composite endpoint cardiovascular events

    Time frame: 24 months

    Cardiovascular hospitalisation or death

Secondary outcomes

  1. Change of individual parameters included in the 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]

  2. Change of NT-proBNP

    Time frame: 24 months

  3. Change of NYHA-class

    Time frame: 24 months

  4. Development or aggravation of albuminuria

    Time frame: 24 months

  5. Change of blood-creatinine

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Acronym: ARTSPREDICTION

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 17, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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