Menu
Recruiting NCT06208007

Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

— Observational Heart Failure With Preserved Ejection Fraction Cardiovascular Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction, Cardiovascular Morbidity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Change in HFA-PEFF-Score [Time frame: 24 months]
  • Development of HFpEF [Time frame: 24 months]
  • Composite endpoint cardiovascular events [Time frame: 24 months]
Secondary outcome measures (5)
  • Change of individual parameters included in the HFA-PEFF-Score [Time frame: 24 months]
  • Change of NT-proBNP [Time frame: 24 months]
  • Change of NYHA-class [Time frame: 24 months]
  • Development or aggravation of albuminuria [Time frame: 24 months]
  • Change of blood-creatinine [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • Universitätsmedizin Göttingen — Göttingen

Identifiers

NCT: NCT06208007 · 9/12/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗