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

June 19, 2012 updated by: Jan Vaclavík
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
25 mg of Spironolactone oraly once daily
Drug: spironolactone
25 mg of spironolactone once daily or placebo for 2 months
PLACEBO_COMPARATOR: 2
placebo oraly once daily
Drug: spironolactone
25 mg of spironolactone once daily or placebo for 2 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Vaclavík

Collaborators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (ESTIMATE)

September 3, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASPIRANT-1
  • EudraCT 2007-003558-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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