Blood Pressure Reduction in Heart Failure

Heart Failure Clinical Trial

— REPIC  

Official title:

Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255475
• Other study ID #: CNPq 474992/2009-8
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 6, 2010
• Last updated: June 6, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Council for Ethics in Research (CONEP)
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Failure
• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Hydralazine/amlodipine
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
• Placebo
Patients will receive placebo

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any cause mortality		12 months after randomization	Yes
Primary	Unplanned hospital admission from any cause		12 months after randomization	Yes
Secondary	Cardiovascular death		12 months after randomization	Yes
Secondary	Acute myocardial ischemia		12 months after randomization	Yes
Secondary	Stroke		12 months after randomization	Yes
Secondary	Symptomatic hypotension		12 months after randomization	Yes
Secondary	Renal function		12 months after randomization	Yes
Secondary	Peak exercise oxygen consumption		12 months after randomization	Yes
Secondary	Quality of life		12 months after randomization	Yes