Addition of Spironolactone in Patients With Resistant Art... | NCT00524615

Studies
Addition of Spironolactone in Patients With Resistant Arterial Hypertension

NCT00524615

Sponsor

Jan Vaclavík

Status

Unknown status

Last Update Posted

Jun 20, 2012Estimated

Enrollment

160Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

spironolactone

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2007-003558-27

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Oct 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Aug 31, 2007

First Submission Date that Met QC Criteria

Aug 31, 2007

First Posted Date

Sep 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2012

Last Update Posted Date

Jun 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan Vaclavík, Principal investigator, University Hospital OlomoucSponsor-Investigator

Lead Sponsor

Jan VaclavíkOTHER

Collaborators

Name	Class
Czech Society of Hypertension	OTHER
Prostejov Hospital	UNKNOWN
Brno University Hospital	OTHER
Olomouc Military Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	25 mg of Spironolactone oraly once daily	Drug: spironolactone
2	Placebo Comparator	placebo oraly once daily	Drug: spironolactone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spironolactone	Drug	25 mg of spironolactone once daily or placebo for 2 months	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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		2 months of follow-up

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Václavík, MD.	Contact	+420588443209		vaclavk.j@centrum.cz

Overall Officials

Name	Affiliation	Role
Jan Václavík, MD.	Internal medicine department I, Olomouc university hospital and Palacký University School of medicine	Study Director
Bořek Lačňák, MD.	Internal Medicine Dept., Šternberk Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olomouc University Hospital and Palacký University School of Medicine	Recruiting	Olomouc		775 20	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17309946	Background	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.
16814132	Background

Type	Date	Date Unknown
Release	Dec 22, 2015
Reset	Jan 28, 2016
Release	Jan 28, 2016
Reset	Feb 26, 2016
Release	Sep 5, 2017
Reset	Mar 30, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 22, 2015			Jan 28, 2016
Jan 28, 2016

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256