- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04420481
Growth Hormone in Ischemic Heart Failure
Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Growth hormon group
A 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period.
|
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.
|
Placebo Comparator: Control group
A 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in left ventricular endsystolic volume
Time Frame: 9 months
|
Measured by CMR
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in enddiastolic volume
Time Frame: 9 months
|
Measured by CMR
|
9 months
|
Change in left ventricular mass
Time Frame: 9 months
|
Measured by CMR
|
9 months
|
Change in left ventricular ejection fraction
Time Frame: 9 months
|
Measured by CMR
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in QoL Questionnaire
Time Frame: 9 months
|
9 months
|
|
Change in NT-proBNP level
Time Frame: 9 months
|
blood sample
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol 2003-03-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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