Hormone Deficiency in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT02976350

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Detailed Description

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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

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Heart Failure Hormone Deficiencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with HFpEF

Male patients with heart failure with preserved ejection fraction

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
* left ventricle ejection fraction \> 50% or more

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Cittadini

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Cittadini, Professor

Role: STUDY_CHAIR

Federico II University

Locations

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Antonio Cittadini

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HormoneHFpEF001

Identifier Type: -

Identifier Source: org_study_id

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