NCT00720525

Brief Summary

Over the past few years, there has been a growing appreciation that a large number of patients with heart failure have a relatively normal (or preserved) ejection fraction (NFNEF). Epidemiologically, HFNEF is most prevalent among elderly women, most of whom have hypertension, diabetes, or both and often coronary artery disease (CAD). Increased arterial stiffness and/or wave reflections have been described in the same patient groups. Therefore, the investigators speculate that pulsatile hemodynamics, representing arterial stiffness and/or arterial wave reflections, 1) may be altered in HFNEF patients, 2) this may contribute to pathophysiology of HFNEF, and 3) this may be used for the diagnosis of the syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

First QC Date

July 18, 2008

Last Update Submit

July 15, 2011

Conditions

Diastolic Heart Failure

Keywords

arterial stiffnessarterial wave reflectionsdiastolic heart failure

Study Arms (2)

1

Patients with diastolic heart failure

2

Patients without diastolic heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing invasive assessment for exertional dyspnea

You may qualify if:

  • exertional dyspnea
  • normal EF (\> 50%)

You may not qualify if:

  • atrial fibrillation
  • more than mild valvular heart disease
  • pericardial disease
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Klinikum Wels-Grieskirchen

Wels, 4600, Austria

Location

Related Publications (1)

  • Weber T, Wassertheurer S, O'Rourke MF, Haiden A, Zweiker R, Rammer M, Hametner B, Eber B. Pulsatile hemodynamics in patients with exertional dyspnea: potentially of value in the diagnostic evaluation of suspected heart failure with preserved ejection fraction. J Am Coll Cardiol. 2013 May 7;61(18):1874-83. doi: 10.1016/j.jacc.2013.02.013. Epub 2013 Mar 6.

    PMID: 23500307DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Thomas Weber, MD

    Cardiology Department, Klinikum Wels-Grieskirchen, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

April 1, 2008

Study Completion

July 1, 2011

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

AU(1)