Heart Failure, SystolicPhase 3NCT04420481
Growth Hormone in Ischemic Heart Failure
A Phase 3 study testing Somatropin in people with Heart Failure, Systolic and Ischemic Heart Disease Chronic, run by Göteborg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic, Ischemic Heart Disease Chronic
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2004to 25 Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
About this study
Official title: Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
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).
Read the 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.
- Being tested
- Somatropin, Placebo
- Keywords
- Heart Failure, Systolic, Ischemic Heart Disease, Growth Hormone Treatment, Insulin Growth Factor I Resistance, Hormone Disturbance
- Medical subject headings
- Heart Failure, Systolic, Myocardial Ischemia, Insulin-Like Growth Factor I, Resistance To, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Growth hormon group | Active comparator | A 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period. Receives: Drug: Somatropin |
| Control group | Placebo comparator | A 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular endsystolic volume
Measured by CMR
Measured: 9 months
Secondary outcomes (3)
Change in enddiastolic volume
Measured by CMR
Measured: 9 months
Change in left ventricular mass
Measured by CMR
Measured: 9 months
Change in left ventricular ejection fraction
Measured by CMR
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 Apr 2004
- Primary completion25 Feb 2012
- Study completion25 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420481
- Sponsor's protocol ID
- Protocol 2003-03-26
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be share upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
- ClinicalTrials.gov ID
- NCT04420481
- Acronym / sponsor ID
- Protocol 2003-03-26
- Keywords
- Heart Failure, Systolic, Ischemic Heart Disease, Growth Hormone Treatment, Insulin Growth Factor I Resistance, Hormone Disturbance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 28 Apr 2004 (actual)
- Primary completion
- 25 Feb 2012 (actual)
- Study completion
- 25 Feb 2012 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Growth hormon group | Active comparator | Drug: SomatropinA 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period. |
| Control group | Placebo comparator | Drug: PlaceboA 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatropinDose: 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. | Drug | Growth hormon group |
| PlaceboPlacebo | Drug | Control group |
Primary outcome
Change in left ventricular endsystolic volume
Time frame: 9 months
Measured by CMR
3 secondary outcomes
Change in enddiastolic volume
Time frame: 9 months
Change in left ventricular mass
Time frame: 9 months
Change in left ventricular ejection fraction
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Yes. Data will be share upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatropin in people with Heart Failure, Systolic and Ischemic Heart Disease Chronic, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular endsystolic volume (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.