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

Completed

• Conditions: Patients With Ischemic or Idiopathic Dilated Cardiomyopathy

• Registration Number: NCT05769387
• Lead Sponsor: IRCCS SYNLAB SDN

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Primary Completion: 2020-01-31
• Study Completion: 2022-05-22
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical and morphological effects where necessary in patients With multiple hormonal deficits in addition to standard medical therapy	1-48 months	Evaluation of the prognostic impact of hormone deficits and miRNA levels in a large population of heart failure patients
Evaluation of the association between hormonal deficits (single or multiple), miRNA profile and clinical/functional indices in patients with heart failure	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

Trial Locations

Locations (1)

IRCCS Synlab SDN; 🇮🇹 Naples, Italy