HypertensionPhase 4NCT00140790
Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study
A Phase 4 study testing valsartan in people with Hypertension, run by Kumamoto University at 2 sites in Japan.
Trial summary
The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2006to Mar 2015
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP) >/= 90 (untreated hypertension cases); or SBP>/=130 and/or DBP>/=80 (treated hypertension cases)
- Patients with coronary artery disease (more than 50% stenosis on coronary angiography [CAG], coronary computed tomography [CT] or coronary magnetic resonance angiography [MRA]; coronary spasm; or history of percutaneous coronary intervention [PCI]);Unstable angina patient
- Creatinine clearance between 30.0 and 89.9 ml/min
Who cannot join
- Reduced left ventricular (LV) function (ejection fraction [EF] equal to or less than 40%)
- Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l)
- Rapid progressive glomerular nephritis
- Nephrotic syndrome
- Renal artery stenosis
- Uncontrolled diabetes (HbA1c equal to or more than 9.0%)
- History of allergy to valsartan
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Department of Cardiovascular Medicine, Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556
About this study
Official title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.
Read the detailed description
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function.
The primary endpoints are:
- cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization, revascularization procedures including coronary angioplasty or coronary artery bypass grafting;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower limbs artery obstruction needing hospitalisation .
- end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
- 50% reduction of creatinine clearance
The secondary endpoints are:
- systolic and diastolic function of the left ventricle estimated by echocardiography (% FS and E/A ratio)
- specific biochemical markers for cardiac or renal function (urine microalbumin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
- % changes of creatinine clearance between start and end of the study period
- transition of 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0
- transition of serum K
- HbA1c
- New onset Atrial Fibrillation
- New onset Diabetes
- Conditions
- Hypertension
- Being tested
- valsartan
- Keywords
- Cardiorenal syndrome, Renal dysfunction, Cardiovascular events, Valsartan
- Medical subject headings
- Hypertension, Cardio-Renal Syndrome, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
valsartan 40 or 160 (80) mg per day
| Study group | Role | What they receive |
|---|---|---|
| Valsartan 40mg | Active comparator | Standard Dose valsartan Receives: Drug: valsartan |
| Valsartan 160mg | Active comparator | High Dose valsartan Receives: Drug: valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Measured: 2 years
End-stage renal dysfunction
Measured: 2 years
50% reduction of creatinine clearance
Measured: 2 years
Secondary outcomes (9)
% FS and E/A ratio
Measured: 2 years
Specific biochemical markers for cardiac or renal function
Measured: 6 months and 1 year and 2 years
% changes of creatinine clearance
Measured: 2 years
1/(serum Cr)
Measured: 2 years
Serum K
Measured: 2 years
HbA1c
Measured: 2 years
U-prot/U-Cr
Measured: 2 years
Adverse drug effects
Measured: 2 years
New onset Atrial Fibrillation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startAug 2006
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisao Ogawa, Kumamoto University
- Investigators
- Hisao Ogawa, MD, PhD, Study chair, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140790
- Sponsor's protocol ID
- CVM-RCT-2005-02
- Status last verified
- Feb 2016
- First submitted
- 31 Aug 2005
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
- ClinicalTrials.gov ID
- NCT00140790
- Acronym / sponsor ID
- CVM-RCT-2005-02
- Conditions
- Hypertension
- Keywords
- Cardiorenal syndrome, Renal dysfunction, Cardiovascular events, Valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Sep 2005 (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 investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.
Detailed description
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function.
The primary endpoints are:
- cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization, revascularization procedures including coronary angioplasty or coronary artery bypass grafting;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower limbs artery obstruction needing hospitalisation .
- end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
- 50% reduction of creatinine clearance
The secondary endpoints are:
- systolic and diastolic function of the left ventricle estimated by echocardiography (% FS and E/A ratio)
- specific biochemical markers for cardiac or renal function (urine microalbumin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
- % changes of creatinine clearance between start and end of the study period
- transition of 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0
- transition of serum K
- HbA1c
- New onset Atrial Fibrillation
- New onset Diabetes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan 40mg | Active comparator | Drug: valsartanStandard Dose valsartan |
| Valsartan 160mg | Active comparator | Drug: valsartanHigh Dose valsartan |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP) >/= 90 (untreated hypertension cases); or SBP>/=130 and/or DBP>/=80 (treated hypertension cases)
- Patients with coronary artery disease (more than 50% stenosis on coronary angiography [CAG], coronary computed tomography [CT] or coronary magnetic resonance angiography [MRA]; coronary spasm; or history of percutaneous coronary intervention [PCI]);Unstable angina patient
- Creatinine clearance between 30.0 and 89.9 ml/min
Key exclusion criteria (8 listed)
- Reduced left ventricular (LV) function (ejection fraction [EF] equal to or less than 40%)
- Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l)
- Rapid progressive glomerular nephritis
- Nephrotic syndrome
- Renal artery stenosis
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 |
|---|---|---|
| valsartanvalsartan 40 or 160 (80) mg per day | Drug | Valsartan 160mg, Valsartan 40mg |
Primary outcome
Cardiovascular events
Time frame: 2 years
End-stage renal dysfunction
Time frame: 2 years
50% reduction of creatinine clearance
Time frame: 2 years
9 secondary outcomes
% FS and E/A ratio
Time frame: 2 years
Specific biochemical markers for cardiac or renal function
Time frame: 6 months and 1 year and 2 years
% changes of creatinine clearance
Time frame: 2 years
1/(serum Cr)
Time frame: 2 years
Serum K
Time frame: 2 years
HbA1c
Time frame: 2 years
U-prot/U-Cr
Time frame: 2 years
Adverse drug effects
Time frame: 2 years
New onset Atrial Fibrillation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
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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.
Hisao Ogawa, MD, PhD study chair
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Hypertension, run by Kumamoto University at 2 sites in Japan.
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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 was stopped early (reason given: The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.). 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?
Cardiovascular events (time frame: 2 years). The study lists 3 primary outcomes in all. 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 26 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.