Rationale and design: the VALsartan In Diastolic Dysfunction (VALIDD) Trial: evolving the management of diastolic dysfunction in hypertension.
BACKGROUND
Although 50% of hypertensive patients in the community are estimated to have diastolic dysfunction, there is no specific guideline for diastolic dysfunction therapy at present despite the condition's clear association with increased cardiovascular risk. Although the efficacy of angiotensin II receptor blockers (ARBs) in hypertension and left ventricular hypertrophy regression has been established, the effect of angiotensin II receptor blockade on intrinsic parameters of diastolic function has not been evaluated in large-scale studies.


METHODS
The VALIDD Trial is an investigator-initiated randomized, controlled, double-blind clinical trial on approximately 350 patients designed to explore whether antihypertensive therapy with the ARB valsartan, in addition to standard therapy, would improve intrinsic diastolic properties of the myocardium in patients with hypertension and evidence of diastolic dysfunction. The result of such therapy will be compared with placebo after 38 weeks of treatment. The primary efficacy variable is change in early diastolic lateral mitral annular relaxation velocity measured by tissue Doppler imaging on week 38.


CONCLUSIONS
We expect the VALIDD Trial to provide novel insights into the specific effects of ARBs on diastolic dysfunction, as assessed by tissue Doppler imaging, in hypertensive patients. The trial may provide clinically useful data on whether such therapy can directly improve diastolic function in patients with hypertension.
Janardhanan
Rajesh
R
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
Daley
William L
WL
Naqvi
Tasneem Z
TZ
Mulvagh
Sharon L
SL
Aurigemma
Gerard
G
Zile
Michael
M
Arnold
J Malcolm O
JM
Artis
Eunice
E
Purkayastha
Das
D
Thomas
James D
JD
Solomon
Scott D
SD
D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D015897:Comorbidity; D003971:Diastole / Q000187:drug effects*; D004311:Double-Blind Method; D015150:Echocardiography, Doppler; D006801:Humans; D006973:Hypertension / Q000453:epidemiology*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013777:Tetrazoles / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068756:Valsartan; D018754:Ventricular Dysfunction / Q000188:drug therapy* / Q000453:epidemiology
D047228:Angiotensin II Type 1 Receptor Blockers; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine