drugset / Trial / NCT04420481

Growth Hormone in Ischemic Heart Failure

NCT04420481

Phase 3 Completed 37 enrolled Göteborg University
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2004-04-28
Primary completion
2012-02-25
Completion
2012-02-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatropin Protein / enzyme biologic 1.4 mg Subcutaneous
Comparator Somatropin Protein / enzyme biologic 4.2 iu Subcutaneous