Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512408
Status:
TERMINATED
Last Update Posted:
2008-10-17
First Post:
2007-08-06
Brief Title:
Testosterone Improves Exercise Oxygen Uptake Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Long-Acting Testosterone Improves Exercise Oxygen Uptake Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Patients with congestive heart failure CHF show muscle mass wasting and decreased testosterone levels Long-term testosterone supplementation improves walking distance and glucose metabolism of patients CHF No studies have investigated the integrated effects of testosterone on exercise oxygen uptake muscle strength and glucose metabolism in patients with CHF regardless of the presence of hypogonadism
Aim To assess the effect of a 12 week testosterone administration on maximal exercise capacity muscle strength and insulin resistance in elderly CHF patients
Methods Seventy elderly patients with stable CHF mean age 71 8 years ejection fraction 34 1 NYHA class IIIII 3832 were enrolled Of these 35 were randomized to receive testosterone therapy through intramuscular injection every 6 week and 35 to receive placebo both on top of maximal medical therapy At baseline and after 12 weeks all patients underwent echocardiogram cardiopulmonary test 6-minute walking test 6MWT quadriceps maximal isometric and isokinetic strength
Aim To assess the effect of a 12 week testosterone administration on maximal exercise capacity muscle strength and insulin resistance in elderly CHF patients
Methods Seventy elderly patients with stable CHF mean age 71 8 years ejection fraction 34 1 NYHA class IIIII 3832 were enrolled Of these 35 were randomized to receive testosterone therapy through intramuscular injection every 6 week and 35 to receive placebo both on top of maximal medical therapy At baseline and after 12 weeks all patients underwent echocardiogram cardiopulmonary test 6-minute walking test 6MWT quadriceps maximal isometric and isokinetic strength
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None