The resynchronization therapy in narrow QRS study (RethinQ study): methods and protocol design

Abstract

Background: Numerous trials have demonstrated the effectiveness of cardiac resynchronization therapy (CRT) as an adjunct to medical therapy for the relief of heart failure (HF) symptoms in patients with a wide QRS duration (QRSd). Current guidelines recommend CRT in patients with an EF <35%, medically refractory NYHA Class III-IV HF and QRSd >or=120 ms. Previous studies have demonstrated QRSd as a marker of electrical dyssynchrony fails to predict response to CRT. In addition, studies have demonstrated significant differences in QRSd post CRT between responders and non-responders. Moreover, smaller non-controlled studies demonstrated that HF patients with a narrow QRSd may benefit from CRT. A growing body of evidence suggests that echocardiographic criteria may be a better method to evaluate mechanical dyssynchrony (MD) which may predict those that will benefit from CRT, particularly those with a narrow QRSd. The Resynchronization Therapy In Narrow QRS (RethinQ) study will evaluate mechanical dyssynchrony using echocardiography (both M mode and TDI) as an eligibility requirement for CRT.

Methods: The RethinQ study is a prospective, multi-center, randomized, double blind controlled clinical study. The objective of the RethinQ study is to evaluate the effectiveness of CRT in patients with approved ICD indication, advanced HF (NYHA Classification III), narrow QRSd (<130 ms) and evidence of MD measured by echocardiography.

Conclusion: We hypothesize that patients with narrow QRS <130 ms, advanced HF, and MD as measured by echocardiography will benefit from CRT.