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Addition of Spironolactone in Patients With Resistant Arterial Hypertension (ASPIRANT)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
spironolactone
Sponsored by
Jan Vaclavík
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring resistant hypertension treatment, spironolactone, aldosterone antagonists, resistant arterial hypertension, refractory arterial hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Olomouc University Hospital and Palacký University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

25 mg of Spironolactone oraly once daily

placebo oraly once daily

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
August 31, 2007
Last Updated
June 19, 2012
Sponsor
Jan Vaclavík
Collaborators
Czech Society of Hypertension, Prostejov Hospital, Brno University Hospital, Olomouc Military Hospital, Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00524615
Brief Title
Addition of Spironolactone in Patients With Resistant Arterial Hypertension
Acronym
ASPIRANT
Official Title
Addition of Spironolactone in Patients With Resistant Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jan Vaclavík
Collaborators
Czech Society of Hypertension, Prostejov Hospital, Brno University Hospital, Olomouc Military Hospital, Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
resistant hypertension treatment, spironolactone, aldosterone antagonists, resistant arterial hypertension, refractory arterial hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
25 mg of Spironolactone oraly once daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo oraly once daily
Intervention Type
Drug
Intervention Name(s)
spironolactone
Intervention Description
25 mg of spironolactone once daily or placebo for 2 months
Primary Outcome Measure Information:
Title
Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)
Time Frame
before and after 2 months of treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Václavík, MD.
Phone
+420588443209
Email
vaclavk.j@centrum.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Václavík, MD.
Organizational Affiliation
Internal medicine department I, Olomouc university hospital and Palacký University School of medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bořek Lačňák, MD.
Organizational Affiliation
Internal Medicine Dept., Šternberk Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Plachý, MD.
Organizational Affiliation
Internal medicine department II, Brno University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olomouc University Hospital and Palacký University School of Medicine
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Václavík, MD.
First Name & Middle Initial & Last Name & Degree
Jan Václavík, MD.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17309946
Citation
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.
Results Reference
background
PubMed Identifier
16814132
Citation
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.
Results Reference
background
PubMed Identifier
25501057
Citation
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.
Results Reference
derived
PubMed Identifier
21804623
Citation
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.
Results Reference
derived
PubMed Identifier
21536989
Citation
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. Erratum In: Hypertension. 2015 Feb;65(2):e7.
Results Reference
derived
Links:
URL
http://www.lf.upol.cz/en/
Description
Palacký University School of Medicine
URL
http://www.fnol.cz/
Description
Olomouc University Hospital

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Addition of Spironolactone in Patients With Resistant Arterial Hypertension

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