Addition of Spironolactone in Patients With Resistant Arterial Hypertension (ASPIRANT)
This study is currently recruiting participants.
Verified June 2012 by University Hospital Olomouc
Sponsor:
Jan Vaclavík
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
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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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Spironolactone
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: | 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
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 May 19, 2013