The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension

NCT01062763 | Completed Phase 3 Results

• 2 other identifiers: EudraCT 2009-017033-222009-017033-22
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Conditions

Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus

Keywords

hypertension; spironolactone; antihypertensive treatment; Type-2 diabetes

Outcome Measures

Primary Outcomes (2)

• Change of of Systolic Blood Pressure

  Change of systolic blood pressure from baseline to study end at four months.

  4 months

• Change of Diastolic Blood Pressure

  Change of diastolic blood pressure from baseline to study end at four months.

  4 months

Secondary Outcomes (1)

• Adverse Effects

  4 months

Study Arms (2)

addition of spironolactone

EXPERIMENTAL

spironolactone is added to previous antihypertensive treatment

Drug: spironolactone

Placebo

PLACEBO COMPARATOR

Addition of placebo

Drug: placebo

Interventions

spironolactone DRUG

25 to 50 mg once daily

addition of spironolactone

placebo DRUG

addition of placebo 1 to 2 tablets daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \< 75 years
• Type-2 diabetes
• Therapy resistant hypertension (by ABPM)
• Treatment with at least 3 antihypertensives

You may not qualify if:

• HbA1c \> 10.0
• BP \> 180/110 mmHg
• Secondary hypertension
• Intolerance to spironolactone
• Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
• Total cholesterol 10 mmol/l
• New York Heart Association class III and IV
• Pregnancy or planned pregnancy
• Psychiatric disease
• Malignant disease
• Insufficient adherence

Sponsors & Collaborators

• Ib Abildgaard Jacobsen: lead

Related Publications (6)

• Elliott HL, Elawad M, Wilkinson R, Singh SP. Persistence of antihypertensive efficacy after missed doses: comparison of amlodipine and nifedipine gastrointestinal therapeutic system. J Hypertens. 2002 Feb;20(2):333-8. doi: 10.1097/00004872-200202000-00025.

  PMID: 11821720 BACKGROUND

• Nishizaka MK, Zaman MA, Calhoun DA. Efficacy of low-dose spironolactone in subjects with resistant hypertension. Am J Hypertens. 2003 Nov;16(11 Pt 1):925-30. doi: 10.1016/s0895-7061(03)01032-x.

  PMID: 14573330 BACKGROUND

• Sharabi Y, Adler E, Shamis A, Nussinovitch N, Markovitz A, Grossman E. Efficacy of add-on aldosterone receptor blocker in uncontrolled hypertension. Am J Hypertens. 2006 Jul;19(7):750-5. doi: 10.1016/j.amjhyper.2005.11.016.

  PMID: 16814132 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.

  PMID: 17309946 BACKGROUND

• Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

  PMID: 33107592 DERIVED

• Oxlund CS, Cangemi C, Henriksen JE, Jacobsen IA, Gram J, Schousboe K, Tarnow L, Argraves WS, Rasmussen LM. Low-dose spironolactone reduces plasma fibulin-1 levels in patients with type 2 diabetes and resistant hypertension. J Hum Hypertens. 2015 Jan;29(1):28-32. doi: 10.1038/jhh.2014.27. Epub 2014 Apr 17.

  PMID: 24739800 DERIVED

MeSH Terms

Conditions

Hypertension; Hypertension Resistant to Conventional Therapy; Diabetes Mellitus

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ib A. Jacobsen
• Organization: Dept. of Endocrinology, Odense University Hospital

ib.abildgaard@rsyd.dk

+45 27203135

Study Officials

• Ib A Jacobsen, DMSc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant physician, associate professor

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 8, 2014
• Results First Posted: May 8, 2014

Record last verified: 2014-04