Effect of Visit-to-Visit Variation of Heart Rate and Systolic Blood Pressure on Outcomes in Chronic Systolic Heart Failure: Results From the Systolic Heart Failure Treatment With the If Inhibitor Ivabradine Trial (SHIFT) Trial.

Abstract

BACKGROUND:

Elevated resting heart rate (HR) and low systolic blood pressure (SBP) are related to poor outcomes in heart failure (HF). The association between visit-to-visit variation in SBP and HR and risk in HF is unknown.

METHODS AND RESULTS:

In Systolic Heart Failure Treatment with the If inhibitor ivabradine Trial (SHIFT) patients, we evaluated relationships between mean HR, mean SBP, and visit-to-visit variations (coefficient of variation [CV]=SD/mean×100%) in SBP and HR (SBP-CV and HR-CV, respectively) and primary composite endpoint (cardiovascular mortality or HF hospitalization), its components, all-cause mortality, and all-cause hospitalization. High HR and low SBP were closely associated with risk for primary endpoint, all-cause mortality, and HF hospitalization. The highest number of primary endpoint events occurred in the highest HR tertile (38.8% vs 16.4% lowest tertile; P<0.001). For HR-CV, patients at highest risk were those in the lowest tertile. Patients in the lowest thirds of mean SBP and SBP-CV had the highest risk. The combination of high HR and low HR-CV had an additive deleterious effect on risk, as did that of low SBP and low SBP-CV. Ivabradine reduced mean HR and increased HR-CV, and increased SBP and SBP-CV slightly.

CONCLUSIONS:

Beyond high HR and low SBP, low HR-CV and low SBP-CV are predictors of cardiovascular outcomes with additive effects on risk in HF, but with an unknown effect size. Beyond HR reduction, ivabradine increases HR-CV. Low visit-to-visit variation of HR and SBP might signal risk of cardiovascular outcomes in systolic HF.

CLINICAL TRIAL REGISTRATION:

URL: http://www.isrctn.com/. Unique identifier: ISRCTN70429960.

• Authors: Michael Böhm, Michele Robertson, Jeffrey Borer, Ian Ford, Michel Komajda, Felix Mahfoud, Sebastian Ewen, Karl Swedberg, Luigi Tavazzi
• Journal: Journal of the American Heart Association (J Am Heart Assoc) Vol. 5 Issue 2 (Feb 12 2016) ISSN: 2047-9980 [Electronic] England
• PMID: 26873681 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Chemical References

• Benzazepines
• Cardiovascular Agents
• Ivabradine

Topics

• Aged
• Benzazepines (adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Cardiovascular Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Heart Failure (diagnosis, drug therapy, mortality, physiopathology)
• Heart Rate (drug effects)
• Hospitalization
• Humans
• Ivabradine
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Office Visits
• Predictive Value of Tests
• Risk Assessment
• Risk Factors
• Systole
• Time Factors
• Treatment Outcome