Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04420481
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2020-06-04
Brief Title:
Growth Hormone in Ischemic Heart Failure
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 14 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
14 mg 42 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 inclusionexclusion 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
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
14 mg 42 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 inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None