Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF (ARTSPREDICTION)

May 8, 2024 updated by: Alexander Schulz, University Medical Center Goettingen
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients at risk for HFpEF

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint cardiovascular events
Time Frame: 24 months
Cardiovascular hospitalisation or death
24 months
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]
24 months
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]
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of NT-proBNP
Time Frame: 24 months
24 months
Change of NYHA-class
Time Frame: 24 months
24 months
Development or aggravation of albuminuria
Time Frame: 24 months
24 months
Change of blood-creatinine
Time Frame: 24 months
24 months
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]
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/12/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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