NCT02976350

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

May 14, 2016

Last Update Submit

November 23, 2016

Conditions

Heart FailureHormone Deficiencies

Keywords

Heart failureHeart failure with preserved ejection fractionGH deficiencyTestosterone deficiencyLow- T3 syndromeMultiple Hormone Deficiencies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Hormone deficiency

    1 months

Study Arms (1)

Patients with HFpEF

Male patients with heart failure with preserved ejection fraction

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male patients with stable chronic heart failure with preserved ejection fraction

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Cittadini

Napoli, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for determination of hormonal levels

MeSH Terms

Conditions

Heart FailureDwarfism, PituitaryEuthyroid Sick Syndromes

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesThyroid Diseases

Study Officials

  • Antonio Cittadini, Professor

    Federico II University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 14, 2016

First Posted

November 29, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

IT(1)