Congestive Heart FailureNCT00512408
Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
An observational study of Congestive Heart Failure, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 to 76 years, men only
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- testosterone
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Mar 2007
- Phase
- Observational
- 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 56 to 76 years
- Men only
- Adult, Older adult
Who may be able to join
- left ventricular ejection fraction (LVEF) < 40%;
- New York Heart Association (NYHA) class II or III;
- clinical stability without hospital admission for heart failure in the previous 3 months.
Who cannot join
- unstable angina or recent acute myocardial infarction,
- history of severe liver diseases
- history of severe kidney diseases
- uncontrolled hypertension
- erythrocytosis (hematocrit > 50%)
- hyperviscosity
- prostate cancer, prostate-specific antigen (PSA) greater than 3 ng/ml
- severe lower urinary tract symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
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 II/III 38/32, 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.
- Conditions
- Congestive Heart Failure
- Being tested
- testosterone
- Keywords
- To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: testosterone | |
| B | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- maurizio volterrani, md, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitgiuseppe marazzi, md, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitmassaro rosalba, md, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitmarco miceli, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitcaterina mammi, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitmassimo fini, md, Principal investigator, IRCCS san Raffaele Cardiovascular Research Unitgiuseppe rosano, md, Study director, IRCCS san Raffaele Cardiovascular Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512408
- Sponsor's protocol ID
- 002-07
- Status last verified
- Aug 2007
- First submitted
- 6 Aug 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
Publications
Schwartz JB, Volterrani M, Caminiti G, Marazzi G, Fini M, Rosano GM, Iellamo F. Effects of testosterone on the Q-T interval in older men and older women with chronic heart failure. Int J Androl. 2011 Oct;34(5 Pt 2):e415-21. doi: 10.1111/j.1365-2605.2011.01163.x. Epub 2011 May 25.
PubMed 21615419
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00512408
- Acronym / sponsor ID
- 002-07
- Conditions
- Congestive Heart Failure
- Keywords
- To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Aug 2007 (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.
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 II/III 38/32, 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: testosterone |
| B | – | – |
Who may qualify
- Ages
- 56 to 76 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- left ventricular ejection fraction (LVEF) < 40%;
- New York Heart Association (NYHA) class II or III;
- clinical stability without hospital admission for heart failure in the previous 3 months.
Key exclusion criteria (8 listed)
- unstable angina or recent acute myocardial infarction,
- history of severe liver diseases
- history of severe kidney diseases
- uncontrolled hypertension
- erythrocytosis (hematocrit > 50%)
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 |
|---|---|---|
| testosterone | Drug | A |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Derived from this study: PubMed 21615419Schwartz JB, Volterrani M, Caminiti G, Marazzi G, Fini M, Rosano GM, Iellamo F. Effects of testosterone on the Q-T interval in older men and older women with chronic heart failure. Int J Androl. 2011 Oct;34(5 Pt 2):e415-21. doi: 10.1111/j.1365-2605.2011.01163.x. Epub 2011 May 25.
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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.
maurizio volterrani, md principal investigator
IRCCS san Raffaele Cardiovascular Research Unit
giuseppe marazzi, md principal investigator
IRCCS san Raffaele Cardiovascular Research Unit
massaro rosalba, md principal investigator
IRCCS san Raffaele Cardiovascular Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by IRCCS San Raffaele 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Oct 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512408, which also lists 1 linked publication.
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 17 Oct 2008.