drugset / Trial / NCT02531490

Early Vascular Adjustments During Hypertensive Pregnancy

NCT02531490

Phase 4 Unknown 368 enrolled Maastricht University Medical Center
RandomizedParallel-groupOpen-labelPrevention

Summary

Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure \<130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.

Timeline

Start
2015-01-01
Primary completion
2023-02
Completion
2023-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Labetalol Small molecule
Comparator Methyldopa Unknown
Comparator Nifedipine Other / unclassified

Indications