Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00591760
• Collaborator: (none)
• Enrollment: 56
• Arms: 2
• Duration (Months): 35

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease	Drug: Somatotropin	Phase 2

Detailed Description

To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GH Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy	Drug: Somatotropin; Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months; Other Names: rhGH Saizen NutropinAq
No Intervention: Placebo PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Outcome Measures

Primary Outcome Measures

1. Peak VO2 [6 months]

   changes in peak VO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Heart Failure in ew York Heart Association functional class II to IV

• Left ventricular end diastolic diameter > 60 mm

• Left ventricular ejection fraction < 40%

• Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl)

• Age 18-80 years

• Clinical stability, guideline-oriented maximal pharmacological therapy

• Informed consent

Exclusion Criteria:

• Active Myocarditis

• Hypertrophic Cardiomyopathy

• Active endocarditis

• Active malignancy

• End stage renal disease

• Severe liver disease (Child B-C)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federico II University

Investigators

• Principal Investigator: Antonio Cittadini, MD, Federico II University - Naples
• Study Chair: Luigi Saccà, MD, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00591760
• Other Study ID Numbers: GH replacement in CHF
• First Posted: Jan 11, 2008
• Last Update Posted: Nov 19, 2012
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Heart Failure; Growth Hormone; Anabolism; Anabolic Deficiency; Hormone replacement
• Additional relevant MeSH terms: Dwarfism, Pituitary; Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Endocrine System Diseases

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Patients recruited during hospital stay were studied after a 3-months period of optimized medical therapy and clinical stability

Arm/Group Title	GH Replacement Therapy	Control
Arm/Group Description	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	Optimal CHF treatment
Period Title: Overall Study
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	GH Replacement Therapy	Control	Total
Arm/Group Description	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	Optimal CHF treatment	Total of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0.0 0%
Between 18 and 65 years	15 53.6%	17 60.7%	32.0 57.1%
>=65 years	13 46.4%	11 39.3%	24.0 42.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (6)	62 (8)	62 (4)
Sex: Female, Male (Count of Participants)
Female	4 14.3%	5 17.9%	9.0 16.1%
Male	24 85.7%	23 82.1%	47.0 83.9%
echocardiography (% of ejection fraction) [Mean (Full Range) ]
Mean (Full Range) [% of ejection fraction]	30	40	35

Outcome Measures

1. Primary Outcome

Title	Peak VO2
Description	changes in peak VO2
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GH Replacement Therapy	Control
Arm/Group Description	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	Optimal CHF treatment
Measure Participants	28	28
Mean (Standard Error) [ml/kg/min]	14.5 (1.0)	12.9 (1.0)

Adverse Events

Arm/Group Title	GH Replacement Therapy		Control
Arm/Group Description	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		Optimal CHF treatment
All Cause Mortality
	GH Replacement Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GH Replacement Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	GH Replacement Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.