Blood Pressure Reduction in Heart Failure | NCT01255475

Studies
Blood Pressure Reduction in Heart Failure

NCT01255475

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Jun 10, 2014Estimated

Enrollment

21Actual

Phase

Phase 2Phase 3

Conditions

Heart Failure
Cardiac Failure
Congestive Heart Failure

Interventions

Hydralazine/amlodipine
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 6, 2010

First Posted Date

Dec 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2014

Last Update Posted Date

Jun 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edimar Alcides Bocchi, Heart Failure Team Directos, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Name	Class
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Drug: Hydralazine/amlodipine
Control	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydralazine/amlodipine	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any cause mortality		12 months after randomization
Unplanned hospital admission from any cause		12 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular death		12 months after randomization
Acute myocardial ischemia		12 months after randomization
Stroke

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

patient refusal
rheumatic or degenerative valvular disease
restrictive cardiomyopathy
evidence of myocardial ischemia
alcohol or drug use
malignant neoplasm
active infection
surgical intervention in the 3 previous months
lactation, childbearing or childbearing potential.
pulmonary embolism in the 6 previous months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edimar A Bocchi, Prof.	Heart Institute (InCor) HC FMUSP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo		São Paulo	São Paulo	05403000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006830	Hydralazine
D017311	Amlodipine

Ancestor Terms

ID	Term
D010793	Phthalazines
D011724	Pyridazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided