The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction

Phase 4 Completed 229 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)\<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of \<140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.

Timeline

Start: 2006-11
Primary completion: 2008-01
Completion: 2008-01

Outcome

Missed primary endpoint

paper with no difference between the 2 strategies in the achieved improvement (P=0.58). PMID 19996069 ↗

Publications

Results Solomon SD, Verma A, Desai A, Hassanein A, Izzo J, Oparil S, Lacourciere Y, Lee J, Seifu Y, Hilkert RJ, Rocha R, Pitt B; Exforge Intensive Control of Hypertension to Evaluate Efficacy in Diastolic Dysfunction Investigators. Effect of intensive versus standard blood pressure lowering on diastolic function in patients with uncontrolled hypertension and diastolic dysfunction. Hypertension. 2010 Feb;55(2):241-8. doi: 10.1161/HYPERTENSIONAHA.109.138529. Epub 2009 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	—
Subject	Amlodipine	Other / unclassified	10 mg	—
Subject	Valsartan	Unknown	160 mg	—
Subject	Valsartan	Unknown	320 mg	—