Double Blind Crossover Comparison of Diuretics in the Young - Full Text View

Sponsor:	University of Cambridge
Collaborator:	British Heart Foundation
Information provided by:	University of Cambridge
ClinicalTrials.gov Identifier:	NCT00429897

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Spironolactone Furosemide Bendroflumethiazide Amiloride

U.S. FDA Resources

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:

Whether the young low-renin hypertensives can be sub-classified according to their most effective diuretic;
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

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
Vascular Diseases
Cardiovascular Diseases
Amiloride
Bendroflumethiazide
Diuretics
Furosemide
Spironolactone
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors
Sodium Potassium Chloride Symporter Inhibitors
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012