Heart FailurePhase 3CANDHEARTNCT00843154
Efficacy of Candesartan on Brain Natriuretic Peptide Levels in Subjects With Chronic Heart Failure
A Phase 3 study testing Candesartan and standard chronic heart disease therapy and Standard chronic heart disease therapy in people with Heart Failure, run by Takeda.
Trial summary
The purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Candesartan and standard chronic heart disease therapy and Standard chronic heart disease therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2008
- Phase
- Phase 3
- 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
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Stable, symptomatic New York Heart Association II-IV Chronic Heart Failure with Left Ventricular Ejection Fraction less than or greater than or greater than or equal to 40% treated with standard therapy including Angiotensin Converting Enzyme-inhibitors and/or beta-blockers. Patients with Left Ventricular Ejection Fraction greater than or equal to 40% had to be hospitalized for cardiovascular events during the past 12 months.
Who cannot join
- History of prior treatment with Angiotensin-Receptor Blockers within two weeks from first.
- Severe or malignant hypertension (Systolic Blood Pressure / Diastolic Blood Pressure greater than 180/110 mmHg).
- Symptomatic hypotension.
- Acute myocardial infarction within one month from first visit.
- Stroke or transient ischemic attack within one month from first visit.
- Percutaneous transluminal coronary angioplasty or coronary artery by-pass graft within one month from first visit.
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- Hemodynamically relevant arrhythmias.
- Implant of pacemakers, cardiac resynchronization therapy or cardioverters within 6 months prior the randomization.
- Hemodynamically relevant cardiac valvular defect.
- Constrictive pericarditis or active myocarditis.
- Likelihood of cardiac surgical intervention (of any type) during the overall treatment period.
- Evidence of angina pectoris in the previous month.
- Poorly controlled diabetes mellitus (glycemia greater than 140mg/mL or glycosylated hemoglobin greater than 8% obtained within three months from the study initiation).
- Untreated thyroid dysfunction.
- Renal artery stenosis.
- Angioedema of any etiology.
- Significant liver (aspartate aminotransferase, alanine aminotransferase, total bilirubin or alkaline phosphatase greater than twice the upper limit of normal range) or renal (serum creatinine greater than 2.0 mg/dL or serum potassium greater than 5.0 mmol/L) impairment.
- Anemia of any etiology (defined as hemoglobin levels less than 10.5 g/dL) or any other clinically relevant hematological disease.
- Any disease with malabsorption.
- Presence of any non-cardiac (e.g. cancer) disease that is likely to significantly (i.e. below 1 year from randomization) shorten life expectancy.
- History of chronic alcohol or drug/substance abuse, or presence of other conditions potentially able to affect study subjects' compliance.
- Known allergy, sensitivity or intolerance to study drugs and/or study drugs' formulation ingredients.
- Participation in another trial in the month preceding study entry.
About this study
Official title: Effects Of Candesartan Cilexetil vs Standard Therapy on Serum Levels of Brain Natriuretic Peptide in Patients Suffering From Chronic Heart Failure With Depressed and Preserved Systolic Function
The purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic heart failure.
Read the detailed description
Chronic heart failure is a significant and increasing cause of morbidity and mortality, accounting for a current yearly prevalence of 5 million and a 5-year survival near 50% in the US. In addition, chronic heart failure is still the fourth cause of hospitalization in the US and in Western countries, and it is the leading cause of hospitalization in patients aged over 65.
Newer pharmacological agents and non pharmacological therapeutic tools have been increasingly introduced to improve the outcomes in patients with chronic heart failure. In the past two decades, several large randomized controlled clinical trials have revolutionized the management and prognosis of patients with chronic heart failure. The recommended drug treatment for decreasing mortality and morbidity in chronic heart failure is based on angiotensin converting enzyme-inhibitors, beta-blockers and aldosterone antagonists (limited to most severe patients), as detailed in the latest European Society of Cardiology guidelines. The use of digitalis and diuretics still has a role.
Orally active angiotensin II type I receptor blockers represent a new class of agents that offer an alternative method of the renin-angiotensin system blockade. Their effects on hemodynamics, neuroendocrine activity and exercise tolerance in patients with chronic heart failure can be considered as similar to that exhibited by angiotensin converting enzyme -inhibitors, but it still remains to be fully elucidated whether angiotensin II type I receptor blockers can offer advantage in efficacy, other than in safety, compared to angiotensin converting enzyme -inhibitors.
Brain Natriuretic Peptide is strongly related to the severity and to the increase of cardiovascular events in patients with chronic heart failure. Recent data show that angiotensin II receptor blockers can reduce the levels of Brain Natriuretic Peptide, though no data is available in patients with preserved left ventricular systolic function.
Candesartan is a selective angiotensin II type I receptor blocker, and this study will evaluate the effects of the maximum tolerated dose of Candesartan added to ongoing standard therapy while measuring changes in brain natriuretic peptide biomarker used in the assessment of chronic heart failure.
- Conditions
- Heart Failure
- Being tested
- Candesartan and standard chronic heart disease therapy, Standard chronic heart disease therapy
- Keywords
- Natriuretic Peptide, Brain, Biological Markers, Biomarkers, Cardiac Failure, Congestive Heart Failure, Heart Decompensation, Drug Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan and standard chronic heart disease therapyDrug
Also called Blopress, Amias, Kenzen, Atacand
Candesartan 4mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for two weeks; then Candesartan increased up to 32mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
Standard chronic heart disease therapyDrug
Candesartan placebo-matching tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Candesartan QD | Experimental | Not described Receives: Drug: Candesartan and standard chronic heart disease therapy |
| Standard chronic heart disease therapy | Active comparator | Not described Receives: Drug: Standard chronic heart disease therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Brain Natriuretic Peptide
Measured: Week 12 or Final Visit.
Secondary outcomes (6)
Change from baseline in Brain Natriuretic Peptide
Measured: Week 48 or Final Visit.
Change from baseline in Aldosterone, Pentraxin-3 and C-Reactive Protein
Measured: Week 48 or Final Visit.
Change from baseline of New York Heart Association class
Measured: Week 48 or Final Visit.
Change from baseline of Left Ventricular Ejection Fraction, Left Ventricular Internal Diastolic Diameter, E wave peak velocity/A wave peak velocity, deceleration time of E wave, atrial dimensions, blood pressure and heart rate
Measured: Week 48 or Final Visit.
Persistence of active treatment and discontinuation rate
Measured: Week 48 or Final Visit.
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
Measured: Week 48 or Final Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startDec 2005
- Primary completionJul 2008
- Study completionJul 2008
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director Director, Study director, Takeda Italia Farmaceutici SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843154
- Sponsor's protocol ID
- CANc-CHF14-TIF
- Other IDs
- 2005-001306-87, U1111-1114-0042, 2005
- Acronym
- CANDHEART
- Status last verified
- Jun 2010
- First submitted
- 12 Feb 2009
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Candesartan Cilexetil vs Standard Therapy on Serum Levels of Brain Natriuretic Peptide in Patients Suffering From Chronic Heart Failure With Depressed and Preserved Systolic Function
- ClinicalTrials.gov ID
- NCT00843154
- Acronym / sponsor ID
- CANDHEART / CANc-CHF14-TIF
- Conditions
- Heart Failure
- Keywords
- Natriuretic Peptide, Brain, Biological Markers, Biomarkers, Cardiac Failure, Congestive Heart Failure, Heart Decompensation, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 571 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Feb 2009 (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 purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic heart failure.
Detailed description
Chronic heart failure is a significant and increasing cause of morbidity and mortality, accounting for a current yearly prevalence of 5 million and a 5-year survival near 50% in the US. In addition, chronic heart failure is still the fourth cause of hospitalization in the US and in Western countries, and it is the leading cause of hospitalization in patients aged over 65.
Newer pharmacological agents and non pharmacological therapeutic tools have been increasingly introduced to improve the outcomes in patients with chronic heart failure. In the past two decades, several large randomized controlled clinical trials have revolutionized the management and prognosis of patients with chronic heart failure. The recommended drug treatment for decreasing mortality and morbidity in chronic heart failure is based on angiotensin converting enzyme-inhibitors, beta-blockers and aldosterone antagonists (limited to most severe patients), as detailed in the latest European Society of Cardiology guidelines. The use of digitalis and diuretics still has a role.
Orally active angiotensin II type I receptor blockers represent a new class of agents that offer an alternative method of the renin-angiotensin system blockade. Their effects on hemodynamics, neuroendocrine activity and exercise tolerance in patients with chronic heart failure can be considered as similar to that exhibited by angiotensin converting enzyme -inhibitors, but it still remains to be fully elucidated whether angiotensin II type I receptor blockers can offer advantage in efficacy, other than in safety, compared to angiotensin converting enzyme -inhibitors.
Brain Natriuretic Peptide is strongly related to the severity and to the increase of cardiovascular events in patients with chronic heart failure. Recent data show that angiotensin II receptor blockers can reduce the levels of Brain Natriuretic Peptide, though no data is available in patients with preserved left ventricular systolic function.
Candesartan is a selective angiotensin II type I receptor blocker, and this study will evaluate the effects of the maximum tolerated dose of Candesartan added to ongoing standard therapy while measuring changes in brain natriuretic peptide biomarker used in the assessment of chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan QD | Experimental | Drug: Candesartan and standard chronic heart disease therapy |
| Standard chronic heart disease therapy | Active comparator | Drug: Standard chronic heart disease therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Stable, symptomatic New York Heart Association II-IV Chronic Heart Failure with Left Ventricular Ejection Fraction less than or greater than or greater than or equal to 40% treated with standard therapy including Angiotensin Converting Enzyme-inhibitors and/or beta-blockers. Patients with Left Ventricular Ejection Fraction greater than or equal to 40% had to be hospitalized for cardiovascular events during the past 12 months.
Key exclusion criteria (23 listed)
- History of prior treatment with Angiotensin-Receptor Blockers within two weeks from first.
- Severe or malignant hypertension (Systolic Blood Pressure / Diastolic Blood Pressure greater than 180/110 mmHg).
- Symptomatic hypotension.
- Acute myocardial infarction within one month from first visit.
- Stroke or transient ischemic attack within one month from first visit.
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 |
|---|---|---|
| Candesartan and standard chronic heart disease therapyAlso: Blopress, Amias, Kenzen, AtacandCandesartan 4mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for two weeks; then Candesartan increased up to 32mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks. | Drug | Candesartan QD |
| Standard chronic heart disease therapyCandesartan placebo-matching tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks. | Drug | Standard chronic heart disease therapy |
Primary outcome
Change from baseline in Brain Natriuretic Peptide
Time frame: Week 12 or Final Visit.
6 secondary outcomes
Change from baseline in Brain Natriuretic Peptide
Time frame: Week 48 or Final Visit.
Change from baseline in Aldosterone, Pentraxin-3 and C-Reactive Protein
Time frame: Week 48 or Final Visit.
Change from baseline of New York Heart Association class
Time frame: Week 48 or Final Visit.
Change from baseline of Left Ventricular Ejection Fraction, Left Ventricular Internal Diastolic Diameter, E wave peak velocity/A wave peak velocity, deceleration time of E wave, atrial dimensions, blood pressure and heart rate
Time frame: Week 48 or Final Visit.
Persistence of active treatment and discontinuation rate
Time frame: Week 48 or Final Visit.
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
Time frame: Week 48 or Final Visit.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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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.
Medical Director Director study director
Takeda Italia Farmaceutici SpA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan and standard chronic heart disease therapy and Standard chronic heart disease therapy in people with Heart Failure, run by Takeda.
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 23 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 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Insufficient enrollment). 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?
Change from baseline in Brain Natriuretic Peptide (time frame: Week 12 or Final Visit.). 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 11 Jun 2010.