Heart FailureMHDS in HFpEFNCT02976350
Hormone Deficiency in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure and Hormone Deficiencies, run by Federico II University at 1 site in Italy.
Trial summary
The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Heart Failure, Hormone Deficiencies
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Sep 2015
- How long will I take part?
- 6 Months
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with stable chronic heart failure with preserved ejection fraction
Who may be able to join
- Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- left ventricle ejection fraction > 50% or more
Who cannot join
- severe liver disease
- serum creatinine levels >2.5 mg/dl
- history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction
The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.
Read the detailed description
Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.
Consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.
- Conditions
- Heart Failure, Hormone Deficiencies
- Keywords
- Heart failure, Heart failure with preserved ejection fraction, GH deficiency, Testosterone deficiency, Low- T3 syndrome, Multiple Hormone Deficiencies
- Medical subject headings
- Heart Failure, Dwarfism, Pituitary, Euthyroid Sick Syndromes
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 |
|---|---|---|
| Patients with HFpEF | Male patients with heart failure with preserved ejection fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hormone deficiency
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionSep 2015
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.
- More trials run by Federico II 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
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cittadini, Federico II University
- Investigators
- Antonio Cittadini, Professor, Study chair, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976350
- Sponsor's protocol ID
- HormoneHFpEF001
- Acronym
- MHDS in HFpEF
- Status last verified
- Nov 2016
- First submitted
- 14 May 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02976350
- Acronym / sponsor ID
- MHDS in HFpEF / HormoneHFpEF001
- Conditions
- Heart Failure, Hormone Deficiencies
- Keywords
- Heart failure, Heart failure with preserved ejection fraction, GH deficiency, Testosterone deficiency, Low- T3 syndrome, Multiple Hormone Deficiencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Nov 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.
The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.
Detailed description
Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.
Consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HFpEF | – | –Male patients with heart failure with preserved ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with stable chronic heart failure with preserved ejection fraction
Key inclusion criteria (2 listed)
- Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- left ventricle ejection fraction > 50% or more
Key exclusion criteria (3 listed)
- severe liver disease
- serum creatinine levels >2.5 mg/dl
- history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months
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
Prevalence of Hormone deficiency
Time frame: 1 months
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 29 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
Antonio Cittadini, Professor study chair
Federico II 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 and Hormone Deficiencies, run by Federico II University at 1 site in Italy.
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 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 29 Nov 2016. 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 Italy. 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?
Prevalence of Hormone deficiency (time frame: 1 months). 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 29 Nov 2016.