Addition of Spironolactone in Patients With Resistant Arterial Hypertension - Full Text View

Sponsor:	University Hospital Olomouc
Collaborators:	Czech Society of Hypertension Sternberk Hospital Brno University Hospital Olomouc Military Hospital Gedeon Richter Ltd.
Information provided by:	University Hospital Olomouc
ClinicalTrials.gov Identifier:	NCT00524615

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: spironolactone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Spironolactone Aldosterone

U.S. FDA Resources

Further study details as provided by University Hospital Olomouc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	160
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 25 mg of Spironolactone once daily	Drug: spironolactone 25 mg of spironolactone once daily or placebo for 2 months
Placebo Comparator: 2 placebo once daily	Drug: spironolactone 25 mg of spironolactone once daily or placebo for 2 months

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524615

Contacts

Contact: Jan Václavík, MD.

+420588443209

vaclavk.j@centrum.cz

Locations

Czech Republic
Olomouc University Hospital and Palacký University School of Medicine	Recruiting
Olomouc, Czech Republic, 775 20
Contact: Jan Václavík, MD.
Principal Investigator: Jan Václavík, MD.

Sponsors and Collaborators

University Hospital Olomouc

Czech Society of Hypertension

Sternberk Hospital

Brno University Hospital

Olomouc Military Hospital

Gedeon Richter Ltd.

Investigators

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

More Information

Publications:

Chapman N, Dobson J, Wilson S, Dahlof 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.

Sharabi Y, Adler E, Shamis A, Nussinovitch N, Markovitz A, Grossman E. Efficacy of add-on aldosterone receptor blocker in uncontrolled hypertension. Am J Hypertens. 2006 Jul;19(7):750-5.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vaclavik J, Sedlak R, Plachy M, Navratil K, Plasek J, Husar R, Kocianova E, Taborsky M. Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT)--study protocol. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Jun;155(2):143-8.

Václavík J, Sedlák R, Plachy M, Navrátil K, Plásek J, Jarkovsky J, Václavík T, Husár R, Kociánová E, Táborsky M. Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT): a randomized, double-blind, placebo-controlled trial. Hypertension. 2011 Jun;57(6):1069-75. Epub 2011 May 2.

Responsible Party:	Jan Václavík, Olomouc Universital Hospital
ClinicalTrials.gov Identifier:	NCT00524615 History of Changes
Other Study ID Numbers:	ASPIRANT-1, EudraCT 2007-003558-27
Study First Received:	August 31, 2007
Last Updated:	February 13, 2009
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by University Hospital Olomouc:

resistant hypertension treatment
spironolactone
aldosterone antagonists
resistant arterial hypertension
refractory arterial hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Aldosterone Antagonists
Spironolactone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012