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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital Olomouc.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Czech Society of Hypertension
Prostejov Hospital
Brno University Hospital
Olomouc Military Hospital
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Jan Vaclavík, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT00524615
First received: August 31, 2007
Last updated: June 19, 2012
Last verified: June 2012
  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 4

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:


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: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jan Vaclavík
Czech Society of Hypertension
Prostejov 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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Vaclavík, Principal investigator, University Hospital Olomouc
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: June 19, 2012
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 July 22, 2014