Growth Hormone in Ischemic Heart Failure

NCT04420481 | Completed Phase 3 DMC

• 1 other identifier: Protocol 2003-03-26
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure, Systolic; Ischemic Heart Disease Chronic

Keywords

Heart Failure, Systolic; Ischemic Heart Disease; Growth Hormone Treatment; Insulin Growth Factor I Resistance; Hormone Disturbance

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular endsystolic volume

  Measured by CMR

  9 months

Secondary Outcomes (3)

• Change in enddiastolic volume

  9 months

• Change in left ventricular mass

  9 months

• Change in left ventricular ejection fraction

  9 months

Other Outcomes (2)

• Change in QoL Questionnaire

  9 months

• Change in NT-proBNP level

  9 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Somatropin DRUG

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.

Growth hormon group

Placebo DRUG

Placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

MeSH Terms

Conditions

Heart Failure, Systolic; Myocardial Ischemia; Insulin-Like Growth Factor I, Resistance To; Endocrine System Diseases

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All care providers and patients were masked with respect to the study drug during the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: April 28, 2004
• Primary Completion: February 25, 2012
• Study Completion: February 25, 2012
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months
• Access Criteria: A researcher that can show previous scientific merits that can be validated