NCT01769079

Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina

Withdrawal of Nitrate in Patients With Stable Angina - Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic treatment of stable angina with nitrates long and short action is extremely frequent. In clinical practice the most commonly observed is a combination of anti-anginal agents, usually including nitrates fixed in an attempt to improve the quality of life of patients, which is not always met with success. Numerous questions and problems are seen with chronic use of oral nitrates. From a practical standpoint, some advocate the withdrawal of medication in stable patients, while many physicians still hesitate to withdraw the medication by the lack of definitive information about its consequences. In this sense there is a rationale for the attempted removal of nitrate fixed these patients, although evidence to support this action have not been adequately evaluated.

Detailed description

The Ischemic Heart Disease remains in recent years as a major cause of mortality in most of the world, and also the disease that consumes more resources in health in industrialized countries. The use of fixed nitrate in patients with stable angina is quite common, but there is a scarcity of studies showing the need for this medication in this class pacientes.Este study aims to evaluate the consequences of the withdrawal of fixed nitrate in patients with stable angina class I and II, hemodynamically stable for the past six months, as the frequency and duration of episodes of angina, silent ischemia and functional capacity by exercise testing, 24-hour Holter and measurement of quality of life and adherence to therapy. For this purpose, a randomized blinded multicenter clinical trial was designed to placebo (intervention group) X nitrate (control group) in a follow-up period for 4 months. Both groups will receive three evaluations (baseline, 30 days and 120 days) during follow-up.

Conditions

• Stable Angina
• Myocardial Ischemia
• Quality of Life

Interventions

Type	Name	Description
DRUG	Nitrate	Two arms: placebo and nitrate
DRUG	Placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-01-16
• Last updated: 2014-01-03

Locations

1 site across 1 country: Brazil