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Cardiovascular DiseasesPhase 3NCT00000525

Diuretics, Hypertension, and Arrhythmias Clinical Trial

A Phase 3 study testing hydrochlorothiazide, diet, potassium supplementation and diet, magnesium supplementation in people with Cardiovascular Diseases and Death, Sudden, Cardiac, run by University of California, San Francisco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death. Read more about this study

Who is it for?
Ages 35 to 70 years, men only
What is being tested?
hydrochlorothiazide, diet, potassium supplementation and diet, magnesium supplementation
How many people
233 participants
Where
No sites listed yet
Study dates
Jul 1986to Sep 1989
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Men, ages 35 to 70, with ECG abnormalities, diastolic blood pressure less than 95 mm Hg at entry.

Subjects had been treated for at least six months by their own physicians with hydrochlorothiazide (HCT), HCT and potassium supplementation, triamteren

About this study

To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

Read the detailed description

BACKGROUND:

The Multiple Risk Factor Intervention Trial (MRFIT) revealed an unexpected subgroup finding: an association between diuretic therapy (especially with hydrochlorothiazide) and an increased rate of sudden death in hypertensive men with left ventricular hypertrophy and other ECG abnormalities. The Diuretics, Hypertension, and Arrhythmias Clinical Trial sought to determine whether the finding resulted from random variation or represented a serious toxic response to hydrochlorothiazide.

DESIGN NARRATIVE:

Randomized, double-blind. Following one month of withdrawal from all diuretics and repletion with oral potassium and magnesium, the study participants were randomized to two months of treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide and triamterene; chlorthalidone; or placebo. The main outcome measures were ventricular arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium levels.

Being tested
hydrochlorothiazide, diet, potassium supplementation, diet, magnesium supplementation, triamterene, chlorthalidone
Medical subject headings
Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Arrest, Heart Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydrochlorothiazideDrug

  • diet, potassium supplementationBehavioural

  • diet, magnesium supplementationBehavioural

  • triamtereneDrug

  • chlorthalidoneDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startJul 1986
  3. Primary completionSep 1989

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Masking
Double blind
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000525
Sponsor's protocol ID
44
Other IDs
R01HL036821
Status last verified
Sep 2013
First submitted
27 Oct 1999
Last updated
19 Sep 2013
Results posted
No

Publications

  • Siegel D, Cheitlin MD, Black DM, Seeley D, Hearst N, Hulley SB. Risk of ventricular arrhythmias in hypertensive men with left ventricular hypertrophy. Am J Cardiol. 1990 Mar 15;65(11):742-7. doi: 10.1016/0002-9149(90)91381-f.

    PubMed 2138408

  • Chang SW, Fine R, Siegel D, Chesney M, Black D, Hulley SB. The impact of diuretic therapy on reported sexual function. Arch Intern Med. 1991 Dec;151(12):2402-8.

    PubMed 1746997

  • Siegel D, Black DM, Seeley DG, Hulley SB. Circadian variation in ventricular arrhythmias in hypertensive men. Am J Cardiol. 1992 Feb 1;69(4):344-7. doi: 10.1016/0002-9149(92)90231-m.

    PubMed 1734646

  • Siegel D, Hulley SB, Black DM, Cheitlin MD, Sebastian A, Seeley DG, Hearst N, Fine R. Diuretics, serum and intracellular electrolyte levels, and ventricular arrhythmias in hypertensive men. JAMA. 1992 Feb 26;267(8):1083-9.

    PubMed 1735925

  • Siegel D, Cheitlin MD, Seeley DG, Black DM, Hulley SB. Silent myocardial ischemia in men with systemic hypertension and without clinical evidence of coronary artery disease. Am J Cardiol. 1992 Jul 1;70(1):86-90. doi: 10.1016/0002-9149(92)91395-k.

    PubMed 1615875

  • Siegel D, Saliba P, Haffner S. Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension. 1994 Jun;23(6 Pt 1):688-94. doi: 10.1161/01.hyp.23.6.688.

    PubMed 8206564

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hydrochlorothiazide, diet, potassium supplementation and diet, magnesium supplementation in people with Cardiovascular Diseases and Death, Sudden, Cardiac, run by University of California, San Francisco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000525, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.

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