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

Jan Vaclavík

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: spironolactone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00524615

ASPIRANT-1

EudraCT 2007-003558-27

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

25 mg of Spironolactone oraly once daily

Treatment:

Drug: spironolactone

2

Placebo Comparator group

Description:

placebo oraly once daily

Treatment:

Drug: spironolactone