Tadalafil for the Treatment of Raynaud's
Status
Conditions
Treatments
Details and patient eligibility
About
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.
Full description
The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- active Raynaud's Phenomenon
- stable disease and medication requirements over the previous 2 months
- subjects willing and able to participate in study assessments
- ability to understand and sign informed consent
- ages 18 to 65, both sexes
- a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria
Exclusion criteria
- uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
- smoking, active alcoholism, drug abuse within 5 years
- abnormal renal function
- ulnar arterial occlusive disease as shown by a positive Allen Test
- Pregnant or breast feeding or considering preg. in next 4 months
- past or present major psych. illness
- allergy or sensitivity to tadalafil
- subject unable to understand protocol or give informed consent
- part. in another study trial within 30 days
- taking sildenafil
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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