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Raynaud's Treatment Study (RTS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000530
First Posted: October 28, 1999
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.

Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Raynaud's Disease Vascular Diseases Drug: nifedipine Behavioral: biofeedback (psychology) Procedure: electromyography Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1992
Estimated Study Completion Date: June 1998
Detailed Description:

BACKGROUND:

Primary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers, but may occur in other extremities as well.

DESIGN NARRATIVE:

Randomized. Patients were assigned to one of four treatment groups: slow release Nifedipine, a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph biofeedback from the frontalis muscle. The primary endpoint was reduction in number of vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including frequency, severity, duration, response to laboratory-based cold challenge, and quality of life.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women with documented primary or secondary Raynaud's syndrome.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000530


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Bruce Thompson Clinical Trials & Surveys Corp (C-TASC)
  More Information

Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: RTS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

ClinicalTrials.gov Identifier: NCT00000530     History of Changes
Other Study ID Numbers: 73
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: April 15, 2016
Last Verified: August 2004

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Raynaud Disease
Peripheral Vascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs