Chronic Heart FailurePhase 4NCT00517426
Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure
A Phase 4 study testing acetazolamide in people with Chronic Heart Failure, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure. Patients will be given CO2 (2%) during a constant workload exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- acetazolamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to Aug 2012
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic heart failure in stable clinical condition
- exercise-induced periodic breathing
Who cannot join
- comorbidities
- NYHA class IV
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure.
Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.
- Conditions
- Chronic Heart Failure
- Being tested
- acetazolamide
- Keywords
- heart failure,, exercise, periodic breathing,, acetazolamide
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
Also called Diamox
i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days
| Study group | Role | What they receive |
|---|---|---|
| Active Acetazolamide | Experimental | Not described Receives: Drug: acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of periodic breathing
Measured: two days
Secondary outcomes (1)
suppression of sleeping apnea
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2011
- Study completionAug 2012
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 Chronic Heart FailureStudies of the same condition, open and under way.
- 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piergiuseppe Agostoni, Centro Cardiologico Monzino
- Investigators
- Piergiuseppe Agostoni, MD, PhD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517426
- Sponsor's protocol ID
- R77-CCM S79/407
- Status last verified
- Jan 2016
- First submitted
- 16 Aug 2007
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
PubMed 17028107
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure
- ClinicalTrials.gov ID
- NCT00517426
- Acronym / sponsor ID
- R77-CCM S79/407
- Conditions
- Chronic Heart Failure
- Keywords
- heart failure,, exercise, periodic breathing,, acetazolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 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.
To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure.
Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Acetazolamide | Experimental | Drug: acetazolamide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic heart failure in stable clinical condition
- exercise-induced periodic breathing
Key exclusion criteria (2 listed)
- comorbidities
- NYHA class IV
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 |
|---|---|---|
| acetazolamideAlso: Diamoxi.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days | Drug | Active Acetazolamide |
Primary outcome
Suppression of periodic breathing
Time frame: two days
1 secondary outcome
suppression of sleeping apnea
Time frame: two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 17028107Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
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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.
Piergiuseppe Agostoni, MD, PhD principal investigator
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetazolamide in people with Chronic Heart Failure, run by Centro Cardiologico Monzino 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suppression of periodic breathing (time frame: two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517426, 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 28 Jan 2016.