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Growth Hormone in Ischemic Heart Failure

Primary Purpose

Heart Failure, Systolic, Ischemic Heart Disease Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Somatropin
Placebo
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Heart Failure, Systolic, Ischemic Heart Disease, Growth Hormone Treatment, Insulin Growth Factor I Resistance, Hormone Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ejection fraction at rest less than 40% at the screening visit as measured by echocardiography and a left ventricular enddiastolic diameter > 32 mm/m2
  • Stable, optimised therapy for heart failure for at least 4 weeks prior to randomisation including Angiotensin converting enzyme inhibitors, or if not tolerated, angiotensin II blockers and/or digitalis. If tolerated patients should receive beta-blockers for heart failure provided they have had a stable dose for at least 3 months prior to randomisation. The dose of diuretics may vary within a given dose-range considered normal for that patient as determined by the investigator.
  • Written informed consent obtained

Exclusion Criteria:

  • Uncontrolled hypertension, treated or not treated with a diastolic blood pressure >105 mm Hg
  • Haemodynamic clinically significant primary valvular disease or significant congenital heart disease
  • Hypertrophic or idiopathic dilated cardiomyopathy
  • Acute pericarditis/myocarditis
  • Echocardiography findings such as mobile thrombus, significant pericardial effusion and significant left ventricular aneurysm
  • Symptomatic or sustained ventricular arrhythmias within the last 3 months not adequately treated with antiarrhythmic drugs or internal cardiovertor defibrillator (ICD)
  • Unstable angina pectoris, or myocardial infarction within last 3 months
  • percutaneous coronary intervention performed within 6 months prior to randomization
  • Planned percutaneous coronary intervention, heart transplantation, other cardiac surgery or other major surgery
  • Atrial fibrillation, if a frequency > 100/min or a large frequency variation, according to clinical judgment
  • Diabetes mellitus, insulin treated
  • Severe liver disease (alanine aminotransferase and/or alanine aminotransferase three times upper limit of normal range laboratory values)
  • Severely reduced renal function (S-Creatinine above 250 micromol/l) or suspected significant renal artery stenosis
  • Uncontrolled endocrine disorders
  • Ongoing treatment with calcium antagonist
  • Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy
  • History of or ongoing malignant disease
  • Previous treatment with growth hormone
  • Patients in a catabolic state
  • Known drug and/or alcohol abuse
  • Inability to cooperate or administer the study drug
  • Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Growth hormon group

    Control group

    Arm Description

    A 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period.

    A 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period.

    Outcomes

    Primary Outcome Measures

    Change in left ventricular endsystolic volume
    Measured by CMR

    Secondary Outcome Measures

    Change in enddiastolic volume
    Measured by CMR
    Change in left ventricular mass
    Measured by CMR
    Change in left ventricular ejection fraction
    Measured by CMR

    Full Information

    First Posted
    June 4, 2020
    Last Updated
    June 5, 2020
    Sponsor
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04420481
    Brief Title
    Growth Hormone in Ischemic Heart Failure
    Official Title
    Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 28, 2004 (Actual)
    Primary Completion Date
    February 25, 2012 (Actual)
    Study Completion Date
    February 25, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Göteborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic heart failure (HF) (ejection fraction (EF) < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).
    Detailed Description
    TITLE: GROWTH HORMONE IN HEART FAILURE Addition of recombinant human growth hormone to standard heart failure therapy in patients with congestive heart failure due to ischaemic heart disease. A 12 month study, consisting of a 9 month double-blind, placebo-controlled randomised growth hormone treatment phase followed by a 3 month growth hormone treatment-free period. STUDY PHASE: III COORDINATING CENTRE: Endocrine Cardiac Unit (ECU) Sahlgrenska University Hospital, Sahlgrenska S-413 45 Göteborg Sweden STUDY PRODUCT: Somatropin, recombinant human growth hormone (rhGH), Saizen® 8 mg (24 IE). CONTROL PRODUCT: Placebo for Saizen® DOSAGE OF STUDY PRODUCT: 1,4 mg (4,2 IE) every other day. DOSAGE: 9 month treatment period and a 3 month follow-up period. ROUTE OF ADMINISTRATION One subcutaneous injection of Saizen® of study product, or corresponding placebo in the thigh or abdomen given in the evening given every other day. STUDY DESIGN: Double-blind (regarding treatment), parallel, placebo-controlled, randomised. STUDY POPULATION: Female and male patients 75 years of age or below with congestive heart failure (NYHA class II or III) due to ischemic heart disease. NUMBER OF PATIENTs: 54 evaluable patients. MULTICENTRE: Yes. NUMBER OF CENTRES: Four ALLOCATION OF TREATMENT: Randomisation to treatment if all inclusion/exclusion criteria are met. PRIMARY OBJECTIVE: To investigate the effect of subcutaneously administered Saizen® compared with placebo on left ventricular endsystolic volume by MRI in patients with congestive heart failure due to ischaemic heart disease. SECONDARY OBJECTIVE: To determine the effect of Saizen® on enddiastolic volume, left ventricular mass and left ventricular ejection fraction TERTIARY OBJECTIVES: To determine the effect of Saizen® on change in NYHA class after 9 months of follow up. To determine the effect of Saizen® on circulating levels of IGF-I and IGFBP-3 and to evaluate the correlation between changes in IGF-I and the respective changes in left ventricular ejection fraction, wall stress and left ventricular mass. To evaluate the effect of Saizen® on quality of life by using two different questionnaires (Minnesota - Living with Heart Failure and Cardiac Health Profile). To determine the effect of Saizen® on neurohormonal activation by measuring NT-proBNP SAFETY VARIABLES: Hospitalization, morbidity and mortality. Clinical events, including tendency to fluid retention, glucose intolerance, arrhythmias and worsening heart failure. Electrolytes, haematology, prothrombin complex, parameters for renal and hepatic function. ADVERSE EVENTS: Spontaneously reported from patients and asked for. To be recorded in Case Report Forms (CRFs) and on separate Adverse Event form if serious Adverse Event. STATISTICS AND DATABASE MANAGEMENT: Data management will be performed by Scandinavian Contract Research Institute and when clean file is declared data will be made available to the statistician for the analysis. The analysis will be performed according to the intention to treat principle.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Systolic, Ischemic Heart Disease Chronic
    Keywords
    Heart Failure, Systolic, Ischemic Heart Disease, Growth Hormone Treatment, Insulin Growth Factor I Resistance, Hormone Disturbance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    A 12 month study, consisting of a 9 months' double-blind, placebo-controlled randomised growth hormone treatment phase followed by a 3 months' growth hormone treatment-free period.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    All care providers and patients were masked with respect to the study drug during the study
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Growth hormon group
    Arm Type
    Active Comparator
    Arm Description
    A 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    A 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period.
    Intervention Type
    Drug
    Intervention Name(s)
    Somatropin
    Intervention Description
    Dose: 1,4 mg (4,2 IE) every other day Dosage: 9 month treatment period and a 3 month follow-up period Administration: One subcutaneous injection of somatropin or corresponding placebo in the thigh or abdomen given in the evening given every other day.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in left ventricular endsystolic volume
    Description
    Measured by CMR
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Change in enddiastolic volume
    Description
    Measured by CMR
    Time Frame
    9 months
    Title
    Change in left ventricular mass
    Description
    Measured by CMR
    Time Frame
    9 months
    Title
    Change in left ventricular ejection fraction
    Description
    Measured by CMR
    Time Frame
    9 months
    Other Pre-specified Outcome Measures:
    Title
    Change in QoL Questionnaire
    Time Frame
    9 months
    Title
    Change in NT-proBNP level
    Description
    blood sample
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ejection fraction at rest less than 40% at the screening visit as measured by echocardiography and a left ventricular enddiastolic diameter > 32 mm/m2 Stable, optimised therapy for heart failure for at least 4 weeks prior to randomisation including Angiotensin converting enzyme inhibitors, or if not tolerated, angiotensin II blockers and/or digitalis. If tolerated patients should receive beta-blockers for heart failure provided they have had a stable dose for at least 3 months prior to randomisation. The dose of diuretics may vary within a given dose-range considered normal for that patient as determined by the investigator. Written informed consent obtained Exclusion Criteria: Uncontrolled hypertension, treated or not treated with a diastolic blood pressure >105 mm Hg Haemodynamic clinically significant primary valvular disease or significant congenital heart disease Hypertrophic or idiopathic dilated cardiomyopathy Acute pericarditis/myocarditis Echocardiography findings such as mobile thrombus, significant pericardial effusion and significant left ventricular aneurysm Symptomatic or sustained ventricular arrhythmias within the last 3 months not adequately treated with antiarrhythmic drugs or internal cardiovertor defibrillator (ICD) Unstable angina pectoris, or myocardial infarction within last 3 months percutaneous coronary intervention performed within 6 months prior to randomization Planned percutaneous coronary intervention, heart transplantation, other cardiac surgery or other major surgery Atrial fibrillation, if a frequency > 100/min or a large frequency variation, according to clinical judgment Diabetes mellitus, insulin treated Severe liver disease (alanine aminotransferase and/or alanine aminotransferase three times upper limit of normal range laboratory values) Severely reduced renal function (S-Creatinine above 250 micromol/l) or suspected significant renal artery stenosis Uncontrolled endocrine disorders Ongoing treatment with calcium antagonist Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy History of or ongoing malignant disease Previous treatment with growth hormone Patients in a catabolic state Known drug and/or alcohol abuse Inability to cooperate or administer the study drug Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be share upon reasonable request
    IPD Sharing Time Frame
    3 months
    IPD Sharing Access Criteria
    A researcher that can show previous scientific merits that can be validated

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    Growth Hormone in Ischemic Heart Failure

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