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

NCT05769387 | Completed

• 1 other identifier: 5-18
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Patients With Ischemic or Idiopathic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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

  1-48 months

• 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

  1-48 months

Study Arms (2)

Patients with no hormonal deficit

Patients with hormonal deficiencies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead

Study Sites (1)

IRCCS Synlab SDN

Naples, 80143, Italy

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: May 23, 2018
• Primary Completion: January 31, 2020
• Study Completion: May 22, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

IT (1)