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The cardiac insufficiency talinolol study (CITAS) study design
1Caritas Hospital Medical School, 29 Traian St., Bucharest, Romania. ingo.weigmann@astamedica.de
Abstract:
Beta-blockers without partial agonist activity are now considered to be strategic therapy for patients with chronic heart failure, but many issues remain to be clarified. The objective of the double-blind, randomized, placebo-controlled cardiac insufficiency talinolol study (CITAS) is to assess efficacy and safety of talinolol - a selective beta-1 adrenoreceptor blocker - in patients with ischemic and non-ischemic heart failure. The primary end-point refers to the influence of talinolol on exercise capacity, evaluated by 6-min walking-test. Secondary end-points consist of left ventricular function, cardiovascular and all-cause mortality, hospitalizations, quality of life, combined clinical end-points and adverse events. There were enrolled 294 patients with stable heart failure in NYHA class II-IV, LVEF <40%, receiving diuretics, ACE-inhibitors and optionally nitrates and digoxin. Talinolol was titrated up to 100 mg/day (one arm) or to 150 mg/d (the other arm), starting with 12.5 mg daily. Enrollment began in November 1997 and the last visit will be in December 2000.
Insights
Talinolol, a beta-1 blocker, was studied in chronic heart failure patients. The Cardiac Insufficiency Talinolol Study (CITAS) assessed its efficacy and safety, focusing on exercise capacity and clinical outcomes.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Beta-blockers without partial agonist activity are key treatments for chronic heart failure.
- Further clarification is needed regarding their optimal use and specific agent effects.
Purpose of the Study:
- To evaluate the efficacy and safety of talinolol, a selective beta-1 adrenoreceptor blocker.
- To assess talinolol's impact on exercise capacity, left ventricular function, mortality, and quality of life in heart failure patients.
Main Methods:
- A double-blind, randomized, placebo-controlled trial (Cardiac Insufficiency Talinolol Study - CITAS).
- 294 patients with stable heart failure (NYHA class II-IV, LVEF <40%) were enrolled.
- Talinolol was titrated to 100 mg/day or 150 mg/day, compared to placebo.
Main Results:
- Primary endpoint: influence of talinolol on exercise capacity via 6-minute walking test.
- Secondary endpoints: left ventricular function, mortality (cardiovascular and all-cause), hospitalizations, quality of life, and adverse events.
- Study enrollment occurred between November 1997 and December 2000.
Conclusions:
- The study aimed to clarify the role of talinolol in managing ischemic and non-ischemic heart failure.
- Results will inform clinical practice regarding the use of selective beta-1 blockers in heart failure.
- The findings will contribute to understanding talinolol's safety profile and overall clinical benefit.
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