Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina
Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stable Angina; Myocardial Ischemia; Quality of Life
Intervention: Nitrate (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital de Clinicas de Porto Alegre Official(s) and/or principal investigator(s): Carisi A Polanczyk, MD, ScD, Principal Investigator, Affiliation: Federal University of Rio Grande do Sul
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.
Clinical Details
Official title: Withdrawal of Nitrate in Patients With Stable Angina - Multicenter Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time of exercise on treadmill test
Secondary outcome: angina function class and time to ischemia on treadmill test
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients of both sexes, aged 18 years or above, with coronary artery disease
documented by angiography or noninvasive test (scintigraphy) with stable angina
functional class I or II of the Canadian Cardiothoracic Society (CCS), clinically
stable for at least six months, using two or more antianginal agents (betablockers or
calcium channel antagonist), among them nitrate fixed.
Exclusion Criteria:
- Patients with residence far from the research center and unable to appropriate
follow-up. Patients with decompensated heart failure symptoms or class III or IV New
York Heart Association (NYHA), poorly controlled hypertension (BP greater than 160/90
mmHg), patients unable to walk or perform stress test and ECG interpretable. Also
excluded were patients in the exercise test pre-randomization present significant
alterations.
Locations and Contacts
Hospital de ClĂnicas de Porto Alegre, Porto Alegre, RS 90035-903, Brazil
Additional Information
Starting date: September 2009
Last updated: January 2, 2014
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