Heart FailurePhase 2/3REPICNCT01255475
Blood Pressure Reduction in Heart Failure
A Phase 2/3 study testing Hydralazine/amlodipine in people with Heart Failure and Cardiac Failure, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Failure, Congestive Heart Failure
- What is being tested?
- Hydralazine/amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 2/3
- 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
- stable chronic heart failure for at least 6 months
- ejection fraction of 40% or less, as measured by transthoracic echocardiography
- optimal clinical treatment for chronic heart failure according to current international guidelines.
Who cannot join
- patient refusal
- rheumatic or degenerative valvular disease
- restrictive cardiomyopathy
- evidence of myocardial ischemia
- alcohol or drug use
- malignant neoplasm
Show all 10Show fewer
- active infection
- surgical intervention in the 3 previous months
- lactation, childbearing or childbearing potential.
- pulmonary embolism in the 6 previous months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure
- Being tested
- Hydralazine/amlodipine, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydralazine/amlodipineDrug
Patients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day
PlaceboDrug
Patients will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: Hydralazine/amlodipine |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any cause mortality
Measured: 12 months after randomization
Unplanned hospital admission from any cause
Measured: 12 months after randomization
Secondary outcomes (7)
Cardiovascular death
Measured: 12 months after randomization
Acute myocardial ischemia
Measured: 12 months after randomization
Stroke
Measured: 12 months after randomization
Symptomatic hypotension
Measured: 12 months after randomization
Renal function
Measured: 12 months after randomization
Peak exercise oxygen consumption
Measured: 12 months after randomization
Quality of life
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionJan 2013
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Edimar Alcides Bocchi, University of Sao Paulo
- Investigators
- Edimar A Bocchi, Prof., Principal investigator, Heart Institute (InCor) HC FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255475
- Sponsor's protocol ID
- CNPq 474992/2009-8
- Acronym
- REPIC
- Status last verified
- Jun 2014
- First submitted
- 6 Dec 2010
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01255475
- Acronym / sponsor ID
- REPIC / CNPq 474992/2009-8
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Dec 2010 (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.
Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Hydralazine/amlodipine |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable chronic heart failure for at least 6 months
- ejection fraction of 40% or less, as measured by transthoracic echocardiography
- optimal clinical treatment for chronic heart failure according to current international guidelines.
Key exclusion criteria (10 listed)
- patient refusal
- rheumatic or degenerative valvular disease
- restrictive cardiomyopathy
- evidence of myocardial ischemia
- alcohol or drug use
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 |
|---|---|---|
| Hydralazine/amlodipinePatients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day | Drug | Intervention |
| PlaceboPatients will receive placebo | Drug | Control |
Primary outcome
Any cause mortality
Time frame: 12 months after randomization
Unplanned hospital admission from any cause
Time frame: 12 months after randomization
7 secondary outcomes
Cardiovascular death
Time frame: 12 months after randomization
Acute myocardial ischemia
Time frame: 12 months after randomization
Stroke
Time frame: 12 months after randomization
Symptomatic hypotension
Time frame: 12 months after randomization
Renal function
Time frame: 12 months after randomization
Peak exercise oxygen consumption
Time frame: 12 months after randomization
Quality of life
Time frame: 12 months after randomization
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 10 Jun 2014.
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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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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.
Edimar A Bocchi, Prof. principal investigator
Heart Institute (InCor) HC FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydralazine/amlodipine in people with Heart Failure and Cardiac Failure, run by University of Sao Paulo at 1 site in Brazil.
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 10 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 10 Jun 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Any cause mortality (time frame: 12 months after randomization). The study lists 2 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 10 Jun 2014; AzTrials last refreshed its copy on 30 Oct 2026.