NCT03775993

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Mar 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

December 12, 2018

Last Update Submit

February 13, 2019

Conditions

Heart FailureGrowth Hormone Deficiency

Keywords

Growth HormonePlaceboExercise capacityVascular reactivityLV functionPrognosis

Outcome Measures

Primary Outcomes (1)

  • Change of peak oxygen consumption (peak VO2)

    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

    1 year

Secondary Outcomes (8)

  • Number of Hospitalizations

    1 year

  • End-systolic LV volumes

    1 year

  • NT-proBNP levels

    1 year

  • Quality of life score from the Minnesota Living with Heart Failure Questionnaire

    1 year

  • Evaluation of Endothelial function (flow-mediated vasodilation)

    1 year

  • +3 more secondary outcomes

Study Arms (2)

GHD

ACTIVE COMPARATOR
Drug: Human growth hormone

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Human growth hormoneDRUG

Administration of growth hormone

GHD
PlaceboOTHER

Administration of placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Marra AM, D'Assante R, De Luca M, Arcopinto M, Gargiulo P, Valente V, Crisci G, Rainone C, Modestino M, Giardino F, Paolillo S, Cacciatore F, Saldamarco L, Bruzzese D, Scarpa D, Filardi PP, Esposito G, Sacca L, Bossone E, Salzano A, Cittadini A. Growth Hormone Replacement Therapy in Heart Failure With Reduced Ejection Fraction: A Randomized, Double-Blind, Placebo-Controlled Trial. JACC Heart Fail. 2025 Apr;13(4):602-614. doi: 10.1016/j.jchf.2024.11.017. Epub 2025 Mar 5.

    PMID: 40047762DERIVED

MeSH Terms

Conditions

Heart FailureDwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Antonio Cittadini, Full Professor of Medicine

CONTACT

+390817464375cittadin@unina.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 14, 2018

Study Start

March 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share