Heart Failure, CongestivePhase 4NCT00490958
Telmisartan in Haemodialysis Patients With Chronic Heart Failure
A Phase 4 study testing telmisartan in people with Heart Failure, Congestive, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- telmisartan
- How many people
- 351 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1999to Jun 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult haemodialysis patients with CHF;
- New York Heart Association (NYHA) class II and III;
- Ejection fraction less or equal to 40% determined within 6 months; and
- Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization
Who cannot join
- Hypotension during dialysis;
- Atrial fibrillation;
- Intolerant to low dose of telmisartan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial
Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.
Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.
Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.
- Conditions
- Heart Failure, Congestive
- Being tested
- telmisartan
- Keywords
- heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
Measured: 36 months
Secondary outcomes (6)
acute non-fatal myocardial infarction
Measured: 36 months
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
Measured: 36 months
cardiovascular hospital admission
Measured: 36 months
nonfatal stroke
Measured: 36 months
coronary revascularization
Measured: 36 months
permanent premature treatment withdrawals
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startJan 1999
- Study completionJun 2005
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 Heart Failure, CongestiveStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Investigators
- Gennaro Cice, MD, Study chair, Chair of cardiology Second University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490958
- Sponsor's protocol ID
- tchf-01-01
- Status last verified
- Nov 2007
- First submitted
- 22 Jun 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.
PubMed 21070920
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
- Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00490958
- Acronym / sponsor ID
- tchf-01-01
- Conditions
- Heart Failure, Congestive
- Keywords
- heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Jun 2005 (actual)
- First posted
- 25 Jun 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: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.
Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.
Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult haemodialysis patients with CHF;
- New York Heart Association (NYHA) class II and III;
- Ejection fraction less or equal to 40% determined within 6 months; and
- Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization
Key exclusion criteria (3 listed)
- Hypotension during dialysis;
- Atrial fibrillation;
- Intolerant to low dose of telmisartan
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 |
|---|---|---|
| telmisartan | Drug | – |
Primary outcome
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
Time frame: 36 months
6 secondary outcomes
acute non-fatal myocardial infarction
Time frame: 36 months
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
Time frame: 36 months
cardiovascular hospital admission
Time frame: 36 months
nonfatal stroke
Time frame: 36 months
coronary revascularization
Time frame: 36 months
permanent premature treatment withdrawals
Time frame: 36 months
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 17 Oct 2008.
- Derived from this study: PubMed 21070920Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.
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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.
Gennaro Cice, MD study chair
Chair of cardiology Second University of Naples
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 telmisartan in people with Heart Failure, Congestive, run by University of Campania Luigi Vanvitelli 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 4 inclusion and 3 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 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.
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?
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure (time frame: 36 months). 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 NCT00490958, 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.