drugset / Trial / NCT04420481
Growth Hormone in Ischemic Heart Failure
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | 1.4 mg | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | 4.2 iu | Subcutaneous |