Addition of Spironolactone in Patients With Resistant Arterial Hypertension

NCT00524615 | Unknown Phase 4

• 2 other identifiers: ASPIRANT-1EudraCT 2007-003558-27
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)

  before and after 2 months of treatment

Secondary Outcomes (1)

• 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

  2 months of follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

25 mg of Spironolactone oraly once daily

Drug: spironolactone

2

PLACEBO COMPARATOR

placebo oraly once daily

Drug: spironolactone

Interventions

spironolactone DRUG

25 mg of spironolactone once daily or placebo for 2 months

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jan Vaclavík: lead
• Czech Society of Hypertension: collaborator
• Prostejov Hospital: collaborator
• Brno University Hospital: collaborator
• Olomouc Military Hospital: collaborator
• Gedeon Richter Ltd.: collaborator

Study Sites (1)

Olomouc University Hospital and Palacký University School of Medicine

Olomouc, 775 20, Czechia

RECRUITING

Related Publications (5)

• 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. doi: 10.1161/01.HYP.0000259805.18468.8c. Epub 2007 Feb 19.

  PMID: 17309946 BACKGROUND

• 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. doi: 10.1016/j.amjhyper.2005.11.016.

  PMID: 16814132 BACKGROUND

• Vaclavik J, Sedlak R, Jarkovsky J, Kocianova E, Taborsky M. Effect of spironolactone in resistant arterial hypertension: a randomized, double-blind, placebo-controlled trial (ASPIRANT-EXT). Medicine (Baltimore). 2014 Dec;93(27):e162. doi: 10.1097/MD.0000000000000162.

  PMID: 25501057 DERIVED

• 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. doi: 10.5507/bp.155.2011.004.

  PMID: 21804623 DERIVED

• Vaclavik J, Sedlak R, Plachy M, Navratil K, Plasek J, Jarkovsky J, Vaclavik T, Husar R, Kocianova E, Taborsky 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. doi: 10.1161/HYPERTENSIONAHA.111.169961. Epub 2011 May 2.

  PMID: 21536989 DERIVED

Related Links

• Palacký University School of Medicine
• Olomouc University Hospital

MeSH Terms

Conditions

Hypertension

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jan Václavík, MD.

  Internal medicine department I, Olomouc university hospital and Palacký University School of medicine

  STUDY DIRECTOR

• Bořek Lačňák, MD.

  Internal Medicine Dept., Šternberk Hospital

  PRINCIPAL INVESTIGATOR

• Martin Plachý, MD.

  Internal medicine department II, Brno University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Václavík, MD.

CONTACT

+420588443209; vaclavk.j@centrum.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

CZ (1)