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Treatment of GHD Associated With CHF

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ClinicalTrials.gov Identifier: NCT03775993
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University

Brief Summary:
Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF

Condition or disease Intervention/treatment Phase
Heart Failure Growth Hormone Deficiency Drug: Human growth hormone Other: Placebo Phase 3

Detailed Description:

Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.

However, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022


Arm Intervention/treatment
Active Comparator: GHD Drug: Human growth hormone
Administration of growth hormone

Placebo Comparator: Placebo Other: Placebo
Administration of placebo




Primary Outcome Measures :
  1. Change of peak oxygen consumption (peak VO2) [ Time Frame: 1 year ]
    According to previous observations, the investigators set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study


Secondary Outcome Measures :
  1. Number of Hospitalizations [ Time Frame: 1 year ]
  2. End-systolic LV volumes [ Time Frame: 1 year ]
  3. NT-proBNP levels [ Time Frame: 1 year ]
  4. Quality of life score from the Minnesota Living with Heart Failure Questionnaire [ Time Frame: 1 year ]
    The questionnaire is comprised of 21 physical, emotional and socioeconomic questions that may adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (lower valure) to 5 (upper value) scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The final score is calculated by sum.

  5. Evaluation of Endothelial function (flow-mediated vasodilation) [ Time Frame: 1 year ]
  6. Muscle strength (handgrip) [ Time Frame: 1 year ]
  7. Evaluation of the Levels of Endothelial Progenitor Cells (EPCs) [ Time Frame: 1 year ]
  8. Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2 [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
  2. age range 18-85 years;
  3. stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
  4. LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
  5. GH deficiency diagnosed with GHRH + arginine provocative test;
  6. signed informed consent.

Exclusion Criteria:

  1. inability to perform a bicycle exercise test;
  2. poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
  3. active and/or history of malignancy;
  4. unstable angina or recent myocardial infarction (less than six months);
  5. severe liver or kidney disease (serum creatinine levels >2.5 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775993


Contacts
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Contact: Antonio Cittadini, Full Professor of Medicine +390817464375 cittadin@unina.it

Sponsors and Collaborators
Federico II University

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Responsible Party: Antonio Cittadini, Full Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03775993     History of Changes
Other Study ID Numbers: 2016-004580-39
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Antonio Cittadini, Federico II University:
Growth Hormone
Placebo
Exercise capacity
Vascular reactivity
LV function
Prognosis

Additional relevant MeSH terms:
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Heart Failure
Endocrine System Diseases
Dwarfism, Pituitary
Heart Diseases
Cardiovascular Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs