Double Blind Crossover Comparison of Diuretics in the Young

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University of Cambridge.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00429897
First received: January 31, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

The principle objective of the study is to determine whether low-renin (i.e. salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over active salt pump in the kidney.

The kidneys have four different salt pumps, and each is blocked by a different type of diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients to respond much better to one diuretic than to the alternatives - rather than responding equally well to all available types of diuretic.


Condition Intervention
Low-Renin Hypertension
Drug: Bendroflumethiazide 2.5mg - 5mg
Drug: Amiloride 20-40mg
Drug: Spironolactone 50-100mg
Drug: Frusemide 20-40mg
Drug: Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Difference in systolic blood pressure for subjects' best drug and second best drug.
  • Difference in plasma renin for subjects' best drug and second best drug.

Secondary Outcome Measures:
  • Predictions of best drug

Estimated Enrollment: 30
Study Start Date: August 2006
Estimated Study Completion Date: July 2007
Detailed Description:

Studies suggest that patients with low renin hypertension respond better to diuretics than other hypertensive drug groups. The aim of the study is to rotate patients through the four main diuretic groups and see if it is possible to identify the most effective diuretic for this group, as measured by a >=10mgHg decrease in Systolic blood pressure in one specific group a compared to the others.

As most caucasians with Low renin hypertension are older (>55), presentation with this type of hypertension at a younger age suggests the presence of substantial genetic variation in order to cause the atypical presentation. It is hoped that by identifying the best diuretic for these patients we will also be able to identify:

  1. Whether the young low-renin hypertensives can be sub-classified according to their most effective diuretic;
  2. Whether this sub-classification helps us to identify the genes and mutations responsible, since these are to expected to be in the so-called sodium channels (i.e. salt pumps)which the kidneys use to prevent salt being excreted in the urine.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-45
  • male or female
  • Hypertensive - 3 clinic SBP >=140mmHg; or 3 clinic DBP >=90mmHg; or ABPM or home BP >=130(SBP) or 85(DBP)
  • 24hr Na+<160mmol/l
  • EITHER {Plasma renin<=10mU/L (measured untreated, or whilst receiving only CCB+/-diuretic} + {Plasma renin <=40mU/L (measured on an ACEi or ARB, which approximately double s the plasma renin)} OR Plasma renin <5mU/L (measured untreated, or receiving any antihypertensive drug other than a beta-blocker

Exclusion Criteria:

  • Documented history of gout
  • Abnormal renal function (both elevated serum creatinine and reduced creatinine clearance
  • SBP > 170mmHg or Diastolic >110mmHg despite treatment with permitted background treatment
  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: NCT00429897

Contacts
Contact: Morris J Brown, Professor 01223 336743 mjb14@medschl.cam.ac.uk

Locations
United Kingdom
University of Cambridge - Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 2QQ
Contact: Morris J Brown, Proffessor    01223 336743    mjb14@medschl.cam.uk   
Sub-Investigator: Sue Hood, RGN - sister         
Sub-Investigator: Diane Picton, RGN- sister         
Sub-Investigator: Tim Burton, Phd, MRCP         
Sponsors and Collaborators
University of Cambridge
British Heart Foundation
Investigators
Principal Investigator: Morris J Brown, Proffessor Cambridge University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429897     History of Changes
Other Study ID Numbers: 1.0
Study First Received: January 31, 2007
Last Updated: January 31, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University of Cambridge:
Hypertension
Low Renin

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amiloride
Bendroflumethiazide
Diuretics
Spironolactone
Acid Sensing Ion Channel Blockers
Antihypertensive Agents
Cardiovascular Agents
Diuretics, Potassium Sparing
Epithelial Sodium Channel Blockers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014