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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

NCTNCT00591760 (opens ClinicalTrials.gov in a new tab)Other idGH replacement in CHF
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names HGH (somatotropin), does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
56 participants (actual)
Sponsor
Federico II University · Other
Design
Randomized · Single masking
Countries
Not stated
Start
Dec 2004
Primary completion
Nov 2007
Completion
Nov 2007
First posted
11 Jan 2008 (estimated)
Last update posted
19 Nov 2012 (estimated)
Conditions
Heart Failure · Growth Hormone Deficiency · Ischemic Heart Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005200620072008
  1. Ph 2

    Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

    NCT00591760

    Dec 2004 to Nov 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

Interventions

  • SomatotropinDrug

Arms2

  • Experimental

    GH

    Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy

  • No intervention

    Placebo

    PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Peak VO2

    Time frame · 6 months

    Registry description

    changes in peak VO2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

Peak VO2

GroupValue (ml/kg/min)Spread
GH Replacement Therapy14.51.0
Control12.91.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GH Replacement TherapyPatients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy–0 / 00 / 0
ControlOptimal CHF treatment–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Heart Failure in ew York Heart Association functional class II to IV * Left ventricular end diastolic diameter \> 60 mm * Left ventricular ejection fraction \< 40% * Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \< 9 ng/dl) * Age 18-80 years * Clinical stability, guideline-oriented maximal pharmacological therapy * Informed consent Exclusion Criteria: * Active Myocarditis * Hypertrophic Cardiomyopathy * Active endocarditis * Active malignancy * End stage renal disease * Severe liver disease (Child B-C)

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