ClinicalTrials.gg
CompletedNCT05769387Updated Mar 15, 2023

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

An observational study in Patients With Ischemic or Idiopathic Dilated Cardiomyopathy, sponsored by IRCCS SYNLAB SDN. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by IRCCS SYNLAB SDN · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Patients With Ischemic or Idiopathic Dilated Cardiomyopathy
03

In context

Cardiomyopathy, Dilated

257 studies on the registry are indexed under Cardiomyopathy, Dilated; 63 are open to participants now.

This study's enrollment of 250 is above the median of 220 across 98 observational studies indexed under Cardiomyopathy, Dilated.

Browse Cardiomyopathy, Dilated studies →

Lead sponsor

IRCCS SYNLAB SDN is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with no hormonal deficit
  • Patients with hormonal deficiencies
06

What researchers measure

Primary outcomes

  1. Evaluation of the association between hormonal deficits (single or multiple), miRNA profile and clinical/functional indices in patients with heart failure

    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

    Time frame: 1-48 months

  2. Evaluation of clinical and morphological effects where necessary in patients With multiple hormonal deficits in addition to standard medical therapy

    Evaluation of the prognostic impact of hormone deficits and miRNA levels in a large population of heart failure patients

    Time frame: 1-48 months

07

Study locations

1 site
  • IRCCS Synlab SDN
    Naples, 80143, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05769387
Lead sponsor
IRCCS SYNLAB SDN
Responsible party
Sponsor
First posted
Mar 15, 2023
Start date
May 23, 2018
Primary completion
Jan 31, 2020
Completion
May 22, 2022
Last update
Mar 15, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion