Chronic Heart FailurePhase 2TOSCA2NCT01235273
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.
A Phase 2 study testing Growth Hormone in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
Trial summary
The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Growth Hormone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
- age range 30-80 years
- stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
- LV ejection fraction 40% or less
- Peak VO2 consumption during a CPET ≤ 16 ml/kg/min.
- LV end-diastolic dimension 55 mm or more
- low IGF-1 levels and a satisfactory response to an IGF-1 generation test
- informed consent
Who cannot join
- haemodynamic clinically significant primary valvular disease or significant congenital heart disease
- acute pericarditis/myocarditis
- inability to perform a bicycle exercise test
- Poorly controlled diabetes mellitus (HbA1c >8.5)
- active proliferative or severe non-proliferative diabetic retinopathy
- active and/or history of malignancy
Show all 12Show fewer
- evidence of progression or recurrence of an underlying intracranial tumor
- unstable angina or recent myocardial infarction (less than 5 months)
- severe liver disease
- serum creatinine levels >2.5 mg/dl
- Inability to cooperate or administer the study drug
- Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels
The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression.
- Conditions
- Chronic Heart Failure
- Being tested
- Growth Hormone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
growth hormone administration
PlaceboOther
standard placebo
| Study group | Role | What they receive |
|---|---|---|
| GH replacement therapy | Experimental | Not described Receives: Drug: Growth Hormone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cittadini, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235273
- Sponsor's protocol ID
- TOSCAproject
- Acronym
- TOSCA2
- Status last verified
- Feb 2014
- First submitted
- 4 Nov 2010
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels
- ClinicalTrials.gov ID
- NCT01235273
- Acronym / sponsor ID
- TOSCA2 / TOSCAproject
- Conditions
- Chronic Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: insufficient enrollment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH replacement therapy | Experimental | Drug: Growth Hormone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
- age range 30-80 years
- stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
- LV ejection fraction 40% or less
- Peak VO2 consumption during a CPET ≤ 16 ml/kg/min.
Key exclusion criteria (12 listed)
- haemodynamic clinically significant primary valvular disease or significant congenital heart disease
- acute pericarditis/myocarditis
- inability to perform a bicycle exercise test
- Poorly controlled diabetes mellitus (HbA1c >8.5)
- active proliferative or severe non-proliferative diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Hormonegrowth hormone administration | Drug | GH replacement therapy |
| Placebostandard placebo | Other | Placebo |
Primary outcome
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Growth Hormone in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.