Raynaud's Treatment Study (RTS) - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000530

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases Raynaud's Disease Vascular Diseases

Drug Information available for: Nifedipine

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women with documented primary or secondary Raynaud's syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000530

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Bruce Thompson

Clinical Trials and Surveys Corporation

More Information

Publications:

Thompson B, Geller NL, Hunsberger S, Frederick M, Hill R, Jacob RG, Smith EA, Kaufmann P, Freedman RR, Wigley FM, Bielory L. Behavioral and pharmacologic interventions: the Raynaud's Treatment Study. Control Clin Trials. 1999 Feb;20(1):52-63.

Jennings JR, Maricq HR, Canner J, Thompson B, Freedman RR, Wise R, Kaufmann PG. A thermal vascular test for distinguishing between patients with Raynaud's phenomenon and healthy controls. Raynaud's Treatment Study Investigators. Health Psychol. 1999 Jul;18(4):421-6.

[No authors listed] Comparison of sustained-release nifedipine and temperature biofeedback for treatment of primary Raynaud phenomenon. Results from a randomized clinical trial with 1-year follow-up. Arch Intern Med. 2000 Apr 24;160(8):1101-8.

Brown KM, Middaugh SJ, Haythornthwaite JA, Bielory L. The effects of stress, anxiety, and outdoor temperature on the frequency and severity of Raynaud's attacks: the Raynaud's Treatment Study. J Behav Med. 2001 Apr;24(2):137-53.

Maricq HR, Jennings JR, Valter I, Frederick M, Thompson B, Smith EA, Hill R. Evaluation of treatment efficacy of Raynaud phenomenon by digital blood pressure response to cooling. Raynaud's Treatment Study Investigators. Vasc Med. 2000;5(3):135-40.

Middaugh SJ, Haythornthwaite JA, Thompson B, Hill R, Brown KM, Freedman RR, Attanasio V, Jacob RG, Scheier M, Smith EA. The Raynaud's Treatment Study: biofeedback protocols and acquisition of temperature biofeedback skills. Appl Psychophysiol Biofeedback. 2001 Dec;26(4):251-78.

Study ID Numbers:	73
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000530 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Raynaud Disease
Peripheral Vascular Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Calcium Channel Blockers

Reproductive Control Agents
Cardiovascular Agents
Nifedipine
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010