Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06208007

Acronym

ARTSPREDICTION

Enrollment

150

Registered

2024-01-17

Start date

2024-02-23

Completion date

2028-01-31

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Morbidity, Heart Failure With Preserved Ejection Fraction

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in HFA-PEFF-Score	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 \[min. 0 points, max. 6 points\]
Development of HFpEF	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 \[min. 0 points, max. 6 points\]
Composite endpoint cardiovascular events	24 months	Cardiovascular hospitalisation or death

Secondary

Measure	Time frame	Description
Development or aggravation of albuminuria	24 months	—
Change of individual parameters included in the HFA-PEFF-Score	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 \[min. 0 points, max. 6 points\]
Change of blood-creatinine	24 months	—
Change of NT-proBNP	24 months	—
Change of NYHA-class	24 months	—

Countries

Germany

Outcome results