Hypertension | Addition of Spironolactone in Patients With Resistant Arterial Hypertension
Hypertension research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:spironolactone25 mg of spironolactone once daily or placebo for 2 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
125 mg of Spironolactone oraly once daily
2placebo oraly once daily
Start Date: September 2007
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)
Secondary Outcome: changes of serum potassium, natrium, creatinine, body weight, casual blood pressure in office, treatment response for different baseline levels of aldosterone and aldosterone/PRA ratio
Study sponsors, principal investigator, and references
Principal Investigator: Jan Václavík, MD.
Lead Sponsor: Jan Vaclavík
Collaborator: Czech Society of Hypertension
Chapman N, Dobson J, Wilson S, Dahlöf B, Sever PS, Wedel H, Poulter NR; Anglo-Scandinavian Cardiac Outcomes Trial Investigators. Effect of spironolactone on blood pressure in subjects with resistant hypertension. Hypertension. 2007 Apr;49(4):839-45. Epub 2007 Feb 19.