Heart FailureNCT04008914
Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure and Preserved Ejection Fraction, run by Ascension Macomb-Oakland Hospital at 1 site in United States.
Trial summary
Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Preserved Ejection Fraction
- What is being tested?
- retrospective observation
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 18 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All
Who may be able to join
- History of Heart failure diagnosis admitted for treatment
- Ejection fraction < 40% by echocardiogram
Who cannot join
- Ejection fraction >40% by echocardiogram
- Chronic Kidney disease requiring dialysis
- Terminal illness
- New onset diagnosis of Heart Failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension Macomb-Oakland Hospital
Warren, Michigan, 48093
About this study
Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.
Read the detailed description
Retrospective review of adults above the age of 18 with a primary diagnosis of HFpEF between August 2017 and March 2018. Subjects had to fall into one of two classifications (NYHA Class II-IV or ACC/AHA Stage B-D) and had a life expectancy greater than 6 months are included. Individuals with a terminal illness other than HF, prior heart transplant or on a transplant list, or current/ planned left ventricular assist device excluded. The primary objective of this study is to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Being tested
- retrospective observation
- Keywords
- Heart Failure, Readmission Risks
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective observationOther
Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.
| Study group | Role | What they receive |
|---|---|---|
| readmission at 30 days | Not described Receives: Other: retrospective observation | |
| readmission at 90 days | Not described Receives: Other: retrospective observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction
Retrospective review to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.
Measured: August 1, 2017 though March 1, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2017
- Primary completion1 Mar 2018
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 only
- Time perspective
- Retrospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Macomb-Oakland Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dustin Harmon, Ascension Macomb-Oakland Hospital
- Investigators
- Dustin Harmon, DO, Principal investigator, Ascension Macomb-Oakland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008914
- Sponsor's protocol ID
- AscensionMacombOaklandH
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04008914
- Acronym / sponsor ID
- AscensionMacombOaklandH
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Keywords
- Heart Failure, Readmission Risks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Ascension Macomb-Oakland HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.
Detailed description
Retrospective review of adults above the age of 18 with a primary diagnosis of HFpEF between August 2017 and March 2018. Subjects had to fall into one of two classifications (NYHA Class II-IV or ACC/AHA Stage B-D) and had a life expectancy greater than 6 months are included. Individuals with a terminal illness other than HF, prior heart transplant or on a transplant list, or current/ planned left ventricular assist device excluded. The primary objective of this study is to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| readmission at 30 days | – | Other: retrospective observation |
| readmission at 90 days | – | Other: retrospective observation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All
Key inclusion criteria (2 listed)
- History of Heart failure diagnosis admitted for treatment
- Ejection fraction < 40% by echocardiogram
Key exclusion criteria (4 listed)
- Ejection fraction >40% by echocardiogram
- Chronic Kidney disease requiring dialysis
- Terminal illness
- New onset diagnosis of Heart Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective observationRetrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed. | Other | readmission at 30 days, readmission at 90 days |
Primary outcome
Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction
Time frame: August 1, 2017 though March 1, 2018
Retrospective review to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.
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 8 Jul 2019.
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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.
Dustin Harmon, DO principal investigator
Ascension Macomb-Oakland Hospital
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 and Preserved Ejection Fraction, run by Ascension Macomb-Oakland Hospital 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 2 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 8 Jul 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?
Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction (time frame: August 1, 2017 though March 1, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019.