Diastolic Heart FailureNCT00720525
Pulsatile and Steady State Hemodynamics in Diastolic Heart Failure
An observational study of Diastolic Heart Failure, run by Klinikum Wels-Grieskirchen at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- How many people
- 362 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2008to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing invasive assessment for exertional dyspnea
Who may be able to join
- exertional dyspnea
- undergoing heart catheterization for diagnosis or exclusion of coronary artery disease
- normal EF (> 50%)
Who cannot join
- atrial fibrillation
- more than mild valvular heart disease
- pericardial disease
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Measures of Pulsatile Versus Steady State Hemodynamics in Diastolic Heart Failure
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.
- Conditions
- Diastolic Heart Failure
- Keywords
- arterial stiffness, arterial wave reflections, diastolic heart failure
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with diastolic heart failure | |
| 2 | Patients without diastolic heart failure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startApr 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Wels-Grieskirchen
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Weber, MD, Principal investigator, Cardiology Department, Klinikum Wels-Grieskirchen, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720525
- Sponsor's protocol ID
- EK 248
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2008
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23500307
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Measures of Pulsatile Versus Steady State Hemodynamics in Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT00720525
- Acronym / sponsor ID
- EK 248
- Conditions
- Diastolic Heart Failure
- Keywords
- arterial stiffness, arterial wave reflections, diastolic heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Klinikum Wels-GrieskirchenUniversity, hospital or other
- Study start
- Apr 2008
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with diastolic heart failure |
| 2 | – | –Patients without diastolic heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing invasive assessment for exertional dyspnea
Key inclusion criteria (3 listed)
- exertional dyspnea
- undergoing heart catheterization for diagnosis or exclusion of coronary artery disease
- normal EF (> 50%)
Key exclusion criteria (4 listed)
- atrial fibrillation
- more than mild valvular heart disease
- pericardial disease
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
- Derived from this study: PubMed 23500307Weber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Weber, MD principal investigator
Cardiology Department, Klinikum Wels-Grieskirchen, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Heart Failure, run by Klinikum Wels-Grieskirchen at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.