Evaluation of the Effect of Human Recombinant Growth Horm... | NCT00182169

Studies
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure

NCT00182169

Sponsor

Hamilton Health Sciences Corporation

Status

Completed

Last Update Posted

Sep 16, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Heart Failure

Interventions

Human recombinant growth hormone

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1997

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 16, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Human recombinant growth hormone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy

Secondary Outcomes

Measure	Description	Time Frame
Cardiac Function measured with radionuclide angiography and echocardiography
Exercise capacity measured during treadmill testing (duration of exercise)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of < 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on "CHF" therapy at the time of randomization.

Exclusion Criteria:

Exercise limited by claudication, angina, neurological, pulmonary (FEV1 < 50%; FVC < 50%), or musculoskeletal disease.
Active known malignancy; remission of < 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
Any other non-cardiac condition that substantially decreases survival.
Significant valvular stenosis or hypertrophic cardiomyopathy.
Unable to comply with GH injection.
Pregnancy or women of child bearing age not using adequate contraceptive means.
Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
Cor pulmonale.
Acute myocarditis.
Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH > 7 or < 0.2) at screening.
Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
Sustained ventricular tachycardia (lasting > 30 seconds) on screening Holter.
Significant liver disease (INR>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase > 3X upper limit of normal; or bilirubin > 2X the upper limit of normal) at baseline.
Failure to give informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Jul 31, 2023
Reset	Mar 8, 2024

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases