Heart Failure With Preserved Ejection FractionNCT01030991
Classification of Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Diastolic Heart Failure, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Diastolic Heart Failure
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2008to 21 May 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with signs or symptoms of heart failure with left ventricular ejection fraction > 50% are eligible for the study
Who may be able to join
- Age > 21 years
- Signs or symptoms of congestive heart failure
- Left ventricular ejection fraction > 50%
Who cannot join
- Severe valvular heart disease
- History of cardiac transplantation
- Prior history of heart failure associated with left ventricular ejection fraction < 35%
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction
The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).
Read the detailed description
Patients with HFpEF are a heterogeneous group with varying etiology and pathophysiology, which may play a large role in the difficulty in managing these patients and enrolling them in clinical trials. A major advance in the care of patients with HFpEF would be a classification system based on etiology, pathophysiology, and/or genetic factors as well as machine learning analyses. The ultimate goal of this study is to demonstrate that it is possible to better classify patients with HFpEF based on etiologic, pathophysiologic, and genetic differences between patients. If successful, this study could lead to: (1) novel risk estimation in patients with HFpEF and (2) more fruitful clinical trials based on targeting specific subsets of HFpEF.
- Keywords
- Heart failure, Ejection fraction, Diastolic heart failure, Diastolic dysfunction, Ventricular-arterial coupling, Exercise testing, Echocardiography, Tissue Doppler imaging, Arterial tonometry, Genetics, Epidemiology
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure
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 |
|---|---|---|
| HFpEF | HFpEF cohort (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure hospitalization
Measured: 1 year
Cardiovascular hospitalization
Measured: 1 year
Mortality - all cause and cardiovascular
Measured: 1 year
Secondary outcomes (1)
Exercise capacity (peak VO2)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start1 Jul 2008
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjiv Shah, Northwestern University
- Investigators
- Sanjiv J Shah, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030991
- Sponsor's protocol ID
- AHA 0835488N
- Status last verified
- May 2019
- First submitted
- 10 Dec 2009
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
PubMed 25398313Rich JD, Burns J, Freed BH, Maurer MS, Burkhoff D, Shah SJ. Meta-Analysis Global Group in Chronic (MAGGIC) Heart Failure Risk Score: Validation of a Simple Tool for the Prediction of Morbidity and Mortality in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2018 Oct 16;7(20):e009594. doi: 10.1161/JAHA.118.009594.
PubMed 30371285Freed BH, Daruwalla V, Cheng JY, Aguilar FG, Beussink L, Choi A, Klein DA, Dixon D, Baldridge A, Rasmussen-Torvik LJ, Maganti K, Shah SJ. Prognostic Utility and Clinical Significance of Cardiac Mechanics in Heart Failure With Preserved Ejection Fraction: Importance of Left Atrial Strain. Circ Cardiovasc Imaging. 2016 Mar;9(3):10.1161/CIRCIMAGING.115.003754 e003754. doi: 10.1161/CIRCIMAGING.115.003754.
PubMed 26941415Unger ED, Dubin RF, Deo R, Daruwalla V, Friedman JL, Medina C, Beussink L, Freed BH, Shah SJ. Association of chronic kidney disease with abnormal cardiac mechanics and adverse outcomes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2016 Jan;18(1):103-12. doi: 10.1002/ejhf.445. Epub 2015 Dec 3.
PubMed 26635076Katz DH, Burns JA, Aguilar FG, Beussink L, Shah SJ. Albuminuria is independently associated with cardiac remodeling, abnormal right and left ventricular function, and worse outcomes in heart failure with preserved ejection fraction. JACC Heart Fail. 2014 Dec;2(6):586-96. doi: 10.1016/j.jchf.2014.05.016. Epub 2014 Oct 1.
PubMed 25282032
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT01030991
- Acronym / sponsor ID
- AHA 0835488N
- Keywords
- Heart failure, Ejection fraction, Diastolic heart failure, Diastolic dysfunction, Ventricular-arterial coupling, Exercise testing, Echocardiography, Tissue Doppler imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 14 Dec 2009 (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.
The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).
Detailed description
Patients with HFpEF are a heterogeneous group with varying etiology and pathophysiology, which may play a large role in the difficulty in managing these patients and enrolling them in clinical trials. A major advance in the care of patients with HFpEF would be a classification system based on etiology, pathophysiology, and/or genetic factors as well as machine learning analyses. The ultimate goal of this study is to demonstrate that it is possible to better classify patients with HFpEF based on etiologic, pathophysiologic, and genetic differences between patients. If successful, this study could lead to: (1) novel risk estimation in patients with HFpEF and (2) more fruitful clinical trials based on targeting specific subsets of HFpEF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | –HFpEF cohort (observational study) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with signs or symptoms of heart failure with left ventricular ejection fraction > 50% are eligible for the study
Key inclusion criteria (3 listed)
- Age > 21 years
- Signs or symptoms of congestive heart failure
- Left ventricular ejection fraction > 50%
Key exclusion criteria (3 listed)
- Severe valvular heart disease
- History of cardiac transplantation
- Prior history of heart failure associated with left ventricular ejection fraction < 35%
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
Heart failure hospitalization
Time frame: 1 year
Cardiovascular hospitalization
Time frame: 1 year
Mortality - all cause and cardiovascular
Time frame: 1 year
1 secondary outcome
Exercise capacity (peak VO2)
Time frame: 1 year
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 23 May 2019.
- Results publication: PubMed 25398313Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
- Derived from this study: PubMed 30371285Rich JD, Burns J, Freed BH, Maurer MS, Burkhoff D, Shah SJ. Meta-Analysis Global Group in Chronic (MAGGIC) Heart Failure Risk Score: Validation of a Simple Tool for the Prediction of Morbidity and Mortality in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2018 Oct 16;7(20):e009594. doi: 10.1161/JAHA.118.009594.
- Derived from this study: PubMed 26941415Freed BH, Daruwalla V, Cheng JY, Aguilar FG, Beussink L, Choi A, Klein DA, Dixon D, Baldridge A, Rasmussen-Torvik LJ, Maganti K, Shah SJ. Prognostic Utility and Clinical Significance of Cardiac Mechanics in Heart Failure With Preserved Ejection Fraction: Importance of Left Atrial Strain. Circ Cardiovasc Imaging. 2016 Mar;9(3):10.1161/CIRCIMAGING.115.003754 e003754. doi: 10.1161/CIRCIMAGING.115.003754.
- Derived from this study: PubMed 26635076Unger ED, Dubin RF, Deo R, Daruwalla V, Friedman JL, Medina C, Beussink L, Freed BH, Shah SJ. Association of chronic kidney disease with abnormal cardiac mechanics and adverse outcomes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2016 Jan;18(1):103-12. doi: 10.1002/ejhf.445. Epub 2015 Dec 3.
- Derived from this study: PubMed 25282032Katz DH, Burns JA, Aguilar FG, Beussink L, Shah SJ. Albuminuria is independently associated with cardiac remodeling, abnormal right and left ventricular function, and worse outcomes in heart failure with preserved ejection fraction. JACC Heart Fail. 2014 Dec;2(6):586-96. doi: 10.1016/j.jchf.2014.05.016. Epub 2014 Oct 1.
- Northwestern University Heart Failure with Preserved Ejection Fraction (HFpEF) ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sanjiv J Shah, MD principal investigator
Northwestern University
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 Heart Failure With Preserved Ejection Fraction and Diastolic Heart Failure, run by Northwestern University at 1 site in United States.
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 3 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 23 May 2019. 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 United States. 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.
What does the primary outcome measure?
Heart failure hospitalization (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030991, which also lists 5 linked publications.
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 23 May 2019.