Trial | NCT00524615  Report issue

Official Title

Addition of Spironolactone in Patients With Resistant Arterial Hypertension

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.
Arterial hypertension resistant to therapy and requiring treatment with more then three antihypertensive drugs is common. At present there are is no standard therapy for resistant hypertension based on randomised clinical trials, neither data to guide addition of further drugs to therapy. Recently some observational and retrospective trials reported good effect of spironolactone in patients with resistant hypertension, but these data were not validated by prospective randomised clinical trials.

This is a multicentric, randomised, double blind clinical trial, which will evaluate the effect of addition of 25 mg spironolactone to current medication compared to placebo. The study will enroll patients with blood pressure over 140/90 mmHg during a clinical examination, which are using at least three antihypertensive drugs, one of them being a diuretic. Average daytime systolic and diastolic blodd pressure will be evaluated by ABPM (ambulatory blood pressure monitoring).
Study Started
Sep 30
2007
Primary Completion
Oct 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Jun 20
2012
Estimate

Drug spironolactone

25 mg of spironolactone once daily or placebo for 2 months

1 Active Comparator

25 mg of Spironolactone oraly once daily

2 Placebo Comparator

placebo oraly once daily

Criteria 

Inclusion Criteria:

Patients over 18 years
Resistant arterial hypertension: (blood pressure during clinical control exceeding 140/90 mmHg (or 130/80 mmHg in in diabetic patients or patients with renal disease with creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic

Exclusion Criteria:

Pregnant or breastfeeding women, women in fertile age without ruled out pregnancy
Severe hypertension over 180/110 mmHg
Renal insufficiency with creatinine over 180 umol/l or GFR lower than 40 ml/min
Hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l
Porphyria
Hypersensitivity to the compounds of Verospiron (Richter Gedeon, Hungary) drug
Patients taking any aldosterone antagonist (spironolactone, eplerenone, kanreone)
No Results Posted