Addition of Spironolactone in Patients With Resistant Arterial Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

August 31, 2007

Last Updated Date

February 13, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring) [ Time Frame: before and after 2 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring) [ Time Frame: before and after 2 months of treatment ]

Change History

Complete list of historical versions of study NCT00524615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 2 months of follow-up ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Official Title ^ICMJE

Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Brief Summary

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.

Detailed Description

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: spironolactone

Study Arms / Comparison Groups

Active Comparator: 25 mg of Spironolactone once daily
Placebo Comparator: placebo once daily

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

September 2009

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jan Václavík, MD.

+420588443209

vaclavk.j@centrum.cz

Location Countries ^ICMJE

Czech Republic

Administrative Information

NCT ID ^ICMJE

NCT00524615

Responsible Party

Jan Václavík, Olomouc Universital Hospital

Study ID Numbers ^ICMJE

ASPIRANT-1, EudraCT 2007-003558-27

Study Sponsor ^ICMJE

University Hospital Olomouc

Collaborators ^ICMJE

Czech Society of Hypertension
Sternberk Hospital
Brno University Hospital
Olomouc Military Hospital
Gedeon Richter Ltd.

Investigators ^ICMJE

Study Director:	Jan Václavík, MD.	Internal medicine department I, Olomouc university hospital and Palacký University School of medicine
Principal Investigator:	Bořek Lačňák, MD.	Internal Medicine Dept., Šternberk Hospital
Principal Investigator:	Martin Plachý, MD.	Internal medicine department II, Brno University Hospital

Information Provided By

University Hospital Olomouc

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP