Trial Outcomes & Findings for Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial (NCT NCT00591760)

NCT ID: NCT00591760

Last Updated: 2012-11-19

Results Overview

changes in peak VO2

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

6 months

Results posted on

2012-11-19

Participant Flow

Sixty-three patients with CHF NYHA class II-IV and GH deficiency were enrolled from December 2004 to December 2006. These patients were consecutively selected from a cohort of 158 ambulatory patients referred to our tertiary care center and, to a minor extent, patients hospitalized for CHF.

Patients recruited during hospital stay were studied after a 3-months period of optimized medical therapy and clinical stability

Participant milestones

Participant milestones
Measure	GH Replacement Therapy Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy	Control Optimal CHF treatment
Overall Study STARTED	28	28
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GH Replacement Therapy n=28 Participants Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy	Control n=28 Participants Optimal CHF treatment	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32.0 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24.0 Participants n=5 Participants
Age Continuous	62 years STANDARD_DEVIATION 6 • n=5 Participants	62 years STANDARD_DEVIATION 8 • n=7 Participants	62 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9.0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	47.0 Participants n=5 Participants
echocardiography	30 % of ejection fraction n=5 Participants	40 % of ejection fraction n=7 Participants	35 % of ejection fraction n=5 Participants

PRIMARY outcome

Timeframe: 6 months

changes in peak VO2

Outcome measures

Outcome measures
Measure	GH Replacement Therapy n=28 Participants Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy	Control n=28 Participants Optimal CHF treatment
Peak VO2	14.5 ml/kg/min Standard Error 1.0	12.9 ml/kg/min Standard Error 1.0

Adverse Events

GH Replacement Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Antonio Cittadini

Federico II University

Phone: 0039(0)817464375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place