This trial is evaluating whether sotatercept will improve 8 primary outcomes and 7 secondary outcomes in patients with PAH. Measurement will happen over the course of From date of first visit up to 200 weeks.
This trial requires 700 total participants across 2 different treatment groups
This trial involves 2 different treatments. Sotatercept is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
More than 50 people die of pah every year in the United States. theme:
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The most common cause of death from Pah is heart disease, but there was no difference in the rates of death from alcohol, intentional injuries, and suicide when comparing Pah deaths with those of the native population of Canada and the United States of America. Pah does not appear to be the most prevalent cause of death and the most prominent health issue among Native people in Canada.\n\nKonopah (Hinuktit-utpi-qalita-tun) is the Nahuatl name for a hallucinogenic drink prepared by mixing maize dough and the juice of the plant "Peucedanum paniculatum".
Most patients (91 %) identified the causes of pah as diabetes, stroke, liver disease, or kidney disease. Other contributing factors included stress and depression (15 % of the patients who reported pah had pah due to anxiety). However many patients who reported pah also reported multiple contributing factors, indicating that stress, anxiety, and pain, may play a role in pah.
Signs of Pah typically appear over several months and persist for 1–2 years. Pah often presents with recurrent headaches and nausea. Other Pah signs include vomiting, constipation, and a foul smell and taste in the mouth. Pah is thought to be a result of a metabolic condition, but more research is required to confirm this.\n
Pah may be related to dietary sources of sodium. In individuals exposed to high amounts of sodium in their diet it may result from the increased volume of sodium being excreted in sweat, leading to a sodium deficit through a positive feedback mechanism. Other sodium-containing beverages, including blackened beverages prepared in households and commercial frozen drinks, may also contribute to this problem. Furthermore, individuals having difficulty controlling fluid intake may be especially affected by increased sodium loss through sweat.
Chronic pah is much more challenging to treat than mild-to-severe pah. Inadequate control of the symptoms that accompany pah may necessitate admission to a long-term care facility. Chronic pah usually responds favorably to antidepressants, whereas acute pah often responds to antipsychotic and atypical antipsychotic therapies. The effectiveness of anti-depressants or antidepressive drugs in pah is a matter of intense debate. Severe pah may need prolonged antipsychotic therapy before improvement can be observed.
Pah is a disorder of the liver and the brain that is caused by a lack of methionine. Pah manifests mainly as chronic fatigue, depression and a tendency towards psychosis. Pah is also considered a disease that is similar to cirrhosis and hepatocellular carcinoma.\n
Many pah patients report multiple forms of complementary/alternative medicine care to address several issues: pah affects their whole body, their symptoms are persistent or fluctuating, and their treatments may be time-consuming, costly, or complicated. While CAM therapies may help some people to decrease pain and improve general symptoms, there is no evidence they change the course or outcome of symptoms, especially if other treatments have not helped.
Based primarily on the safety and tolerability data available for people, sotatercept demonstrates a favorable safety profile and should not be withheld from people based on race, sex or age.
Pah may be diagnosed for the first time in adolescence or adulthood. As there aren't any established screening criteria for pah, it's difficult to identify patients that could benefit from clinical trials and treatment. Clinical trials are therefore the best alternative for pah patients. If an individual is considering clinical trials, Power.com can help you join a trial or search for one that fits your current condition (http://www.withpower.com/d/pah-clinics-trials).
Treatment with rhPTH led to significant improvements in quality of life for the majority of patients, regardless of age or gender. A significant proportion of patients (10.0%) reported an overall QoL improvement (increased or unchanged) and more than half recorded improvements in several domains. Further efforts are needed to develop and evaluate treatments specifically enhancing physical and social QoL for this high-risk population, particularly among those of male sex, older age, and with a less progressive disease process.
Sotatercept seems effective for treating pah in children with advanced stage pah and is not effective in children with mild pah. It is effective in adults with advanced pah. It is not reliable to predict the response of sotatercept on the basis of the baseline response. The response should be examined within a randomized controlled trial first, and then monitored by a healthcare team using a standardized protocol.