HypertensionPhase 4NCT00241098
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
A Phase 4 study testing valsartan in people with Hypertension and Congestive Heart Failure, run by Novartis.
Trial summary
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Hypertension, Congestive Heart Failure
- What is being tested?
- valsartan
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- May 2003to 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 25-85 years of age, inclusive
- Past diagnosis of hypertension for a min 1 year
- Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months
- BP is considered adequately controlled with DBP < 90mmHg
- Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory
- LV ejection fraction ³ 45%
Show all 11Show fewer
- LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females
- At least one of the following parameters of diastolic dysfunction
- E/A < 1 for the patients who are younger than 55 years or < 0.8 for the patients whose age is ³ 55 years (full year), or
- DT > 220 ms, or
- IVRT > 90 ms
Who cannot join
- Present use of ACE inhibitor
- Other protocol-defined exclusion criteria may apply.
- -
About this study
Official title: A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
- Conditions
- Hypertension, Congestive Heart Failure
- Being tested
- valsartan
- Keywords
- HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
- Medical subject headings
- Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary outcomes (5)
Change from baseline in a blood measurement for heart failure after 12 weeks
Change in baseline heart size after 26 weeks
Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
Change from baseline in markers of heart fibrosis after 26 weeks
Change from baseline quality of life questionnaire after 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startMay 2003
- Primary completionJun 2005
- Study completionJun 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceutical, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241098
- Sponsor's protocol ID
- CVAL489B2402
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2005
- Last updated
- 18 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study
- ClinicalTrials.gov ID
- NCT00241098
- Acronym / sponsor ID
- CVAL489B2402
- Conditions
- Hypertension, Congestive Heart Failure
- Keywords
- HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 18 Oct 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.
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female 25-85 years of age, inclusive
- Past diagnosis of hypertension for a min 1 year
- Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months
- BP is considered adequately controlled with DBP < 90mmHg
- Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory
Key exclusion criteria (3 listed)
- Present use of ACE inhibitor
- Other protocol-defined exclusion criteria may apply.
- -
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 |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
Change from baseline in a blood measurement for heart failure after 26 weeks
5 secondary outcomes
Change from baseline in a blood measurement for heart failure after 12 weeks
Change in baseline heart size after 26 weeks
Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
Change from baseline in markers of heart fibrosis after 26 weeks
Change from baseline quality of life questionnaire after 26 weeks
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 18 Oct 2023.
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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.
Novartis Pharmaceutical study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Hypertension and Congestive Heart Failure, run by Novartis.
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 11 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 18 Oct 2023. 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 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?
Change from baseline in a blood measurement for heart failure after 26 weeks. 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 18 Oct 2023.