Multihormonal Deficiencies and miRNA Profile in Chronic Heart Failure: Effects of Combined Hormonal Replacement Therapy

March 3, 2023 updated by: IRCCS SYNLAB SDN
The results from this study will be useful to gain detailed information on the correlation related to pathophysiological aspects between endocrine system and clinical status of patients with heart failure, and to identify factors correlated with the progression and prognosis of ICC

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80143
        • Irccs Synlab Sdn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Enrollment of no. 250 subjects with CCI. The patients will be recruited from among patients belonging to the UOC of Internal Medicine with Cardiology and Respiratory Address of the AOU Federico II in Naples and the Division of Cardiology "San Giovanni di Dio and Ruggi d'Aragona" Salerno

Description

Inclusion Criteria:

  • ischemic or idiopathic dilated cardiomyopathy, stable medications for at least three months including ß-blocker that must be started at least 6 months before entering the study, fraction of left ventricular ejection less than or equal to 49%

Exclusion Criteria:

  • Age < 18 years, Inability to perform a bicycle ergometer exercise test. Diabetes mellitus in poor glycometabolic control and/or proliferative retinopathy or nonproliferative retinopathy severe grade. Severe renal failure; Hepatic cirrhosis advanced. Active neoplastic disease or history of malignancy. Patients with severe acute illness caused by complications from open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. Active infection or sepsis. Any allergies to growth hormone, testosterone, vitamin D, or other excipients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or methacresol. Acute Coronary Syndrome within the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with no hormonal deficit
Patients with hormonal deficiencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the association between hormonal deficits (single or multiple), miRNA profile and clinical/functional indices in patients with heart failure
Time Frame: 1-48 months
Patients will be followed with the goal of determining whether the deficits hormonal deficits have an impact on prognosis. In the pilot study, a significant benefit is expected in terms of improved quality of life and physical performance of patients following adequate hormone replacement treatment. In addition, the clinical relevance of the association between anabolic deficits (single or multiple), miRNA expression profile, vitamin D levels, and clinical/functional indices in patients with HCI in order to identify novel biomarkers for the progression of human collagenase inhibitor HCI
1-48 months
Evaluation of clinical and morphological effects where necessary in patients With multiple hormonal deficits in addition to standard medical therapy
Time Frame: 1-48 months
Evaluation of the prognostic impact of hormone deficits and miRNA levels in a large population of heart failure patients
1-48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS SYNLAB SDN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

May 22, 2022

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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