Blood Pressure Reduction in Heart Failure

Phase 2

Completed

• Conditions: Cardiac Failure; Congestive Heart Failure; Heart Failure
• Interventions: Drug: Hydralazine/amlodipine; Drug: Placebo

• Registration Number: NCT01255475
• Lead Sponsor: University of Sao Paulo

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 available

Study Timeline

• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Study Start: 2011-01
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Hydralazine/amlodipine	-
Control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Any cause mortality	12 months after randomization
Unplanned hospital admission from any cause	12 months after randomization

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	12 months after randomization
Acute myocardial ischemia	12 months after randomization
Stroke	12 months after randomization
Symptomatic hypotension	12 months after randomization
Renal function	12 months after randomization
Peak exercise oxygen consumption	12 months after randomization
Quality of life	12 months after randomization

Trial Locations

Locations (1)

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil