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Raynaud Disease clinical trials

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NCT ID: NCT03129178 Completed - Raynaud Phenomenon Clinical Trials

Beet the Cold: The Effect of Inorganic Nitrate Supplementation in Individuals With Raynaud's Phenomenon

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Individuals with Raynaud's phenomenon often experience episodes of reduced blood flow to their fingers and toes during times of stress or cold exposure, causing significant discomfort and pain. Typically, treatment for these individuals involves using drugs like Glyceryl Trinitrate (GTN), which increases blood flow to the fingers and toes by increasing a substance called nitric oxide in the blood. Unfortunately, repeated use of these drugs increases tolerance to them, meaning higher doses are required to produce the same effect. However, increasing the dose can cause more side effects like headaches, and is therefore not considered an ideal long-term therapy. Leafy green vegetables, especially beetroot, contain high amounts of nitrate and are beneficial to blood vessel health, since nitrate from the diet can also be turned into the important blood vessel relaxer, nitric oxide. Unlike GTN, people don't appear to develop a tolerance to dietary nitrate or experience negative side effects. Therefore, this study aims to see if short and longer term beetroot juice supplementation can improve blood flow to the hands and feet in individuals with Raynaud's phenomenon, as well as reduce their pain. This study will tell us how many people are needed for a definitive trial investigating whether beetroot juice can help treat Raynaud's phenomenon. Raynaud's phenomenon can cause significant discomfort and pain to individuals. Dietary nitrate appears to offer a simple, low cost means of improving blood flow to the hands and feet which should reduce both the discomfort and pain experienced characterising this condition. This study will advance our understanding of the causes of Raynaud's phenomenon, specifically the role that the nitrate-nitrite-nitric oxide pathway might play in changing Raynaud's phenomenon symptoms and identifying targets for intervention.

NCT ID: NCT03094910 Completed - Diabetes Mellitus Clinical Trials

Investigation of the Rewarming og the Fingers After Cooling and the Autonomic Nervous System in Raynaud's Phenomenon

RaynAUT
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Patients with Raynaud's disease have an increased tendency of chest pain and migraine, and studies indicate that the disease might be associated with increased cardiovascular morbidity and mortality. Furthermore, a certain hyperactivity of the sympathetic nervous system has been demonstrated in these patients. Hyperactivity of the sympathetic nervous system is known to cause decreasing heart function, regardless of the underlying disease. The cardiac autonomic nervous function and thermographic parameters will be assessed in patients with primary and secondary Raynaud's phenomenon and glaucoma as well as in patients diagnosed with autonomic dysfunction such as diabetics and patients with Parkinson's disease in order to compare the function of the cardiac autonomic nervous system and the peripheral response to cold exposure. Potentially, this will lead to a better understanding of the cardiac autonomic nervous function in Raynaud's phenomenon. Moreover, it might give rise to a new perception of the condition and its association to cardiovascular disease. At the Department of Clinical Physiology, the current method of detecting Raynaud's phenomenon is time-consuming and unpleasant to the patient due to cooling for several minutes. Another aim of the PhD study is to implement infrared thermography as a gentler and possibly more sensitive method to replace the currently applied method. The project will also include an epidemiological study based on data obtained from the National Patient Registry, among others. Raynaud's phenomenon will be paired with diagnostic codes of conditions such as diabetes mellitus, Parkinson's disease, glaucoma, and cardiovascular disease.

NCT ID: NCT03058887 Completed - Quality of Life Clinical Trials

The Effects of Exercise in Patients With Systemic Sclerosis

Start date: June 2016
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a multisystem connective tissue disease characterised by vascular abnormalities and fibrosis, including those of the skin and can be categorised as either Limited cutaneous scleroderma or Diffuse cutaneous scleroderma. It is estimated that more than 90% of patients with SSc experience Raynaud's phenomenon (RP) at regular intervals during the course of their disease. Approximately 50% of patients with SSc develop severe digital ischaemia and/or ulceration which seems to be painful, difficult to heal, susceptible to infections and heavily influences quality of life and increases SSc-related disability. Medical treatment is commonly used as an effective first line approach in the NHS policy when uncontrolled RP attacks emerge. However, considering the short-term side effects (oedema, headaches, heart palpitations, dizziness and constipation) but also the long-term side effects of nifedipine (heart dysfunction and increased cardiovascular risk) as well as the financial cost of this approach, alternative approaches with less side effects and less cost implications are warranted. An alternative approach would be to implement a programme of therapeutic exercise that would be suitable for this patient group. To the investigators knowledge the efficacy of exercise on microcirculation in RP has not been previously examined. In this regard, high intensity interval training (HIIT) has come to prominence over the last years for its effectiveness in inducing greater improvements in vascular function than moderate intensity continuous training. Due to the variation in HIIT protocols evidence is limited to support which protocol is the most effective in SSc patients. Moreover, it should be noted that the chief aim of the research project is to encourage long-term adherence to physical activity and rehabilitation programmes in these patients which might be beneficial for the vascular function. A short HIIT protocol (30seconds/passive recovery) may elicit more favourable patient reported satisfaction /enjoyment levels compared to other longer exercise duration protocols. A short HIIT protocol (30seconds/passive recovery) has demonstrated to be well tolerated, preferred protocol with a low perception of effort, patient comfort and with a longer time spent at high percentage of V̇O2peak than a longer HIIT protocol with active recovery phases in chronic heart failure patients. More recent evidence supports this notion; when enjoyment levels in an overweight/obese cohort were examined after a short HIIT protocol. Although it is known that HIIT is capable to improve vascular function and potentially the microcirculatory parameters, evidence is scarce regarding the mode of exercise that will be more effective on digital microcirculation where the RP attacks are present in SSc patients. Assumptions could be made that utilising an upper-body exercise would potentially be more beneficial for the digital microcirculation rather than lower-body exercise where the working muscles promote the blood flow in the lower limbs. Hence, the differential effects that may occur by the upper- and lower-limb exercise on the digital microcirculation in SSc patients should be examined. Resistance training (RT) alone has shown significant improvements in the function of the vasculature; moreover, a combination of aerobic and RT have shown both in the past and recently important enhances in the vascular function and microcirculation. However, the limited number of studies have investigated the effects of RT on vasculature bespeaks a lack of concrete evidence. Moreover, to the investigators knowledge the effects of combined exercise (RT and aerobic exercise) utilising a HIIT protocol and RT on microcirculation has yet to be examined. Aims: The primary aim of the present study is to examine the feasibility of exercise in patients with Systemic Sclerosis experiencing Raynaud's Phenomenon.

NCT ID: NCT03027674 Completed - Clinical trials for Lupus Erythematosus, Systemic

Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud

Start date: August 2016
Phase: N/A
Study type: Interventional

Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients with secondary Raynaud's phenomenon (RP). Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10 patients with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the other hand were applied. The thumbs didn't receive any cream and served as a control group. The primary outcome was the improvement of blood flow and vessel diameter of the digital arteries measured by high frequency color Doppler ultrasound before and 1 hour after treatment.

NCT ID: NCT02688270 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Connective Tissue Disease

Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.

NCT ID: NCT02683408 Completed - Raynaud's Disease Clinical Trials

Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon

Start date: February 2016
Phase: N/A
Study type: Interventional

Diosmiplex is a product marketed for the management of diseases due to venous and microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of small arteries and impaired microvascular flow. This study will examine the effects of diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.

NCT ID: NCT02680509 Completed - Raynauds Clinical Trials

Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study

Start date: February 2016
Phase: N/A
Study type: Interventional

The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.

NCT ID: NCT02583789 Completed - Clinical trials for Raynaud's Phenomenon

Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon

Start date: May 2016
Phase: Early Phase 1
Study type: Interventional

This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjects will be randomized to receive oral treprostinil sustained release tablets or matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed for 12 weeks of treatment with oral UT-15C during the study.

NCT ID: NCT02506062 Completed - Raynaud Disease Clinical Trials

A Trial of Ischemic Preconditioning in Raynaud's Phenomenon (RP)

Start date: July 2015
Phase: N/A
Study type: Interventional

This trial will test the efficacy of brief periods of controlled limb ischemia (remote ischemic preconditioning, RIPC) as an effective treatment of patients with Raynaud's Phenomenon (RP).The hypothesis of this trial is that due to its vasoprotective effects, RIPC would be more effective than placebo in the treatment of both primary and secondary RP, as defined by decreased frequency, duration, and severity of attacks. This trial was also designed to monitor the tolerance of RIPC in a rheumatologic population. Patients will not be required to stop any current treatment for RP.

NCT ID: NCT02396238 Completed - Systemic Sclerosis Clinical Trials

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)

STAR
Start date: May 15, 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.