Hormone Deficiency in Heart Failure With Preserved Ejection Fraction

Heart Failure Clinical Trial

— MHDS in HFpEF  

Official title:

Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976350
• Other study ID #: HormoneHFpEF001
• Status: Completed
• Phase: N/A
• First received: May 14, 2016
• Last updated: November 23, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endocrine System Diseases
• Heart Failure
• Hormone Deficiencies

Locations

Country	Name	City	State
Italy	Antonio Cittadini	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Hormone deficiency		1 months	No