Heart Failure, DiastolicNCC-HFNCT02946476
Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients
An observational study of Heart Failure, Diastolic and Heart Failure, Systolic, run by Ospedale Maggiore Di Trieste.
Trial summary
To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Heart Failure, Systolic
- What is being tested?
- prognostic impact of non cardiac comorbidities
- How many people
- 2,314 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2014
- 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: We studied all consecutive heart failure patients with diagnostic codes presenting clinical findings compatible with heart failure
Who may be able to join
- All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit
Who cannot join
- We excluded all patients who had severe primary left-sided valvular disease
About this study
Official title: Prevalence and Prognostic Impact of Noncardiac Comorbidities in Heart Failure Outpatients With Preserved and Reduced Ejection Fraction: A Community-Based Study
To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.
- Conditions
- Heart Failure, Diastolic, Heart Failure, Systolic
- Being tested
- prognostic impact of non cardiac comorbidities
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognostic impact of non cardiac comorbiditiesOther
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | patients with heart failure and reduced ejection fraction Receives: Other: prognostic impact of non cardiac comorbidities | |
| HFpEF | patients with heart failure and preserved ejection fraction Receives: Other: prognostic impact of non cardiac comorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality
Measured: 2 years
Secondary outcomes (3)
First all-cause hospitalization
Measured: 2 years
Heart Failure hospitalization
Measured: 2 years
noncardiovascular hospitalization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Maggiore Di Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Iorio, Ospedale Maggiore Di Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946476
- Sponsor's protocol ID
- OMTrieste
- Acronym
- NCC-HF
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognostic Impact of Noncardiac Comorbidities in Heart Failure Outpatients With Preserved and Reduced Ejection Fraction: A Community-Based Study
- ClinicalTrials.gov ID
- NCT02946476
- Acronym / sponsor ID
- NCC-HF / OMTrieste
- Conditions
- Heart Failure, Diastolic, Heart Failure, Systolic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,314 participants (actual)
- Lead sponsor
- Ospedale Maggiore Di TriesteUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Oct 2016 (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.
To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFrEF | – | Other: prognostic impact of non cardiac comorbiditiespatients with heart failure and reduced ejection fraction |
| HFpEF | – | Other: prognostic impact of non cardiac comorbiditiespatients with heart failure and preserved ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We studied all consecutive heart failure patients with diagnostic codes presenting clinical findings compatible with heart failure
Key inclusion criteria (1 listed)
- All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit
Key exclusion criteria (1 listed)
- We excluded all patients who had severe primary left-sided valvular disease
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 |
|---|---|---|
| prognostic impact of non cardiac comorbidities | Other | HFpEF, HFrEF |
Primary outcome
overall mortality
Time frame: 2 years
3 secondary outcomes
First all-cause hospitalization
Time frame: 2 years
Heart Failure hospitalization
Time frame: 2 years
noncardiovascular hospitalization
Time frame: 2 years
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 27 Oct 2016.
Related trials for Heart Failure, Diastolic
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Diastolic and Heart Failure, Systolic, run by Ospedale Maggiore Di Trieste.
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 1 inclusion and 1 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
overall mortality (time frame: 2 years). 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 27 Oct 2016.