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

NCT ID: NCT05769387

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-23

Study Completion Date

2022-05-22

Brief Summary

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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

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Conditions

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Patients With Ischemic or Idiopathic Dilated Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with no hormonal deficit

No interventions assigned to this group

Patients with hormonal deficiencies

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS SYNLAB SDN

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Synlab SDN

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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5-18

Identifier Type: -

Identifier Source: org_study_id

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