2025 marks a transformative year in the field of pulmonary arterial hypertension (PAH) treatment in India. For those living with this debilitating condition, hope has always been a distant dream. However, the availability of sotatercept—a groundbreaking biologic therapy—has breathed new life into the PAH field. As one of the first institutions to introduce sotatercept for PAH patients in India, we’ve witnessed some of the most remarkable clinical improvements that highlight not just the potential of the drug, but also the resilience and courage of the patients and caregivers who inspire us every day.
Dr. Prashant Bobhate, a highly experienced pulmonary hypertension specialist in Mumbai, India, has been at the forefront of this clinical innovation. Sotatercept, which has already shown significant promise in global clinical trials, is now delivering real-world results that are hard to ignore. This blog outlines the early experience of sotatercept use for the first four PAH patients in India, and the profound impact it has had on their quality of life.
The Indian PAH Context: Why This Matters
Younger Patients: The average age of diagnosis is about a decade earlier than in Europe.
Higher CTD-PAH Rates: More patients have PAH related to connective tissue diseases like systemic sclerosis.
Delayed Diagnosis: Many patients are diagnosed at later stages (WHO Functional Class III or IV).
Limited Access to Therapy: Parenteral prostanoids, key for high-risk cases, are not widely available in India.
Financial and Logistical Barriers: Long-term treatments like subcutaneous or intravenous therapy are difficult for many patients outside major cities
Given these challenges, sotatercept’s subcutaneous dosing every three weeks offers a practical advantage, making it easier for patients to manage their treatment while potentially reducing the need for more intensive therapies. Dr. Prashant Bobhate, Pediatric Cardiologist in Mumbai, emphasizes the need for accessible treatment options, particularly in underserved areas, where patients face greater hurdles in managing their condition.
Patient Profiles: The First Four Cases
In this section, we highlight the first four cases of Pulmonary Arterial Hypertension (PAH) treated with sotatercept (brand name Winrevair) at Kokilaben Dhirubhai Ambani Hospital, Mumbai. These patients under the care of Dr Prashant Bobhate were suffering from severe PAH. Importantly, three of the patients were totally dependent on their wheelchairs at the time of the first visit. After continuing the treatment for over six months, the patients exhibited remarkable improvement that was comparable to the outcomes of the global STELLAR trial. This local experience highlights the high efficacy of sotatercept in bringing a positive change to the lives of patients with advanced PAH.
Patient 1: Idiopathic PAH, WHO FC III, 34-Year-Old Female
A young woman with a two-year history of idiopathic PAH (IPAH), on dual therapy (ambrisentan + tadalafil), with persistently poor functional status (6MWD: 265 m) and elevated NT-proBNP. Sotatercept was initiated at 0.3 mg/kg, with planned escalation to 0.7 mg/kg.
Clinical Outcomes:
6MWD improvement: +47 meters.
NT-proBNP decline: 38%.
Symptom improvement: Reported meaningful reduction in dyspnoea on exertion.
Tolerability: Escalated to target dose with no significant adverse events, only mild transient erythema at the injection site after the first dose.
Patient 2: Systemic Sclerosis-Associated PAH, WHO FC III, 52-Year-Old Female
A patient with limited cutaneous systemic sclerosis and PAH on triple oral therapy (ambrisentan + tadalafil + selexipag), with persistently intermediate-high risk hemodynamics. Given the disease progression and desire to avoid parenteral escalation, sotatercept was added.
Clinical Outcomes:
Reduction in PVR: 28% at 16 weeks (RHC repeat).
WHO functional class improvement: From FC III to FC II.
Safety: Mild thrombocytopenia (platelet count nadir: 118 x 10^9/L), requiring a brief dose delay but no discontinuation.
Patient 3: PAH Associated with Repaired Congenital Heart Disease, WHO FC II, 29-Year-Old Male
A young male with repaired ventricular septal defect and residual PAH, on dual therapy, with an intermediate-risk profile based on the REVEAL Lite 2 score. Sotatercept was initiated due to persistent hemodynamic evidence of active vascular disease despite vasodilator therapy.
Clinical Outcomes:
Improvement in exercise capacity: Notable improvement after 12 weeks.
Echocardiogram results: Reduction in estimated right ventricular systolic pressure.
Tolerability: The patient tolerated therapy without incident.This case highlights the potential role of sotatercept in PAH associated with congenital heart disease, a group not well-represented in pivotal trials.
Patient 4: CTD-PAH (MCTD), WHO FC II-III, 44-Year-Old Female
A patient with mixed connective tissue disease (MCTD) and PAH, on dual therapy, who had remained stable but not improved over 18 months. Sotatercept was added to target residual disease activity and vascular remodeling.
Clinical Outcomes:
6MWD improvement: +34 meters at 16 weeks.
NT-proBNP: Showed a downward trend.
Quality of life improvement: Patient reported improved daily function.
Hemoglobin: Rose from 11.8 g/dL to 13.4 g/dL, an expected effect of ActRIIA inhibition, no intervention needed.
Expanding Beyond Treatment: Impactful Research and Collaboration
At Kokilaben Dhirubhai Ambani Hospital, our journey with sotatercept is just one part of a larger commitment to improving outcomes for PAH patients in India. Led by Dr. Prashant Bobhate, a renowned Pediatric Cardiologist in Mumbai, we are pushing the boundaries of PAH research and collaboration:
Digital Stethoscope and AI-based Early Detection: We are developing innovative tools for early diagnosis of CHD and PAH using advanced digital stethoscopes and AI technologies to detect cardiovascular anomalies at the earliest stages, leading to better outcomes.
Multicenter Yoga Study: Initiated with 35 patients, this study focuses on the potential of yoga as an adjunct to traditional PAH treatments, helping patients improve functional capacity and quality of life.
ICMR-Recognized Centre of Excellence for PAH: Our institution is actively participating in three national clinical studies to further understand PAH and its treatment in the Indian context.
These initiatives, combined with the positive clinical outcomes from sotatercept therapy, underscore the transformative changes happening in PAH care in India. We are not only providing better treatments but also striving to make early detection and holistic care a reality for all patients.
Conclusion: A Pivotal Moment for Indian PAH Care
Sotatercept is redefining the treatment of Pulmonary Arterial Hypertension (PAH) in India. Early experiences, including four patients at Kokilaben Dhirubhai Ambani Hospital, show significant improvements in functional capacity, haemodynamics, and disease risk profile, aligning with global trial results.
For Indian clinicians, sotatercept represents a shift from vasodilatory management to disease modification, especially for patients with CTD-PAH and limited access to parenteral alternatives. As access expands and more real-world data is collected, larger registries will help assess its performance in India’s unique patient population.
2025 marks a hopeful year for PAH care in India, with sotatercept leading the way in changing the treatment landscape and improving patient outcomes across the country.
FAQs
How is sotatercept different from other PAH drugs?
Other than medications that dilate blood vessels, sotatercept works differently as it focuses on vascular remodeling by blocking activin signaling, thus hitting the root cause of PAH.
Can sotatercept be used alone as a first, line treatment?
In general, sotatercept is designed to be used with other PAH medications, and it is an add, on therapy rather than a solo treatment option.
How is sotatercept given, and can I self, inject?
Sotatercept is administered to patients via a subcutaneous injection every 21 days, and if properly trained, patients can perform the injections themselves at home.
What monitoring is needed while on sotatercept?
Monitoring will often include blood tests (hemoglobin, platelets), echocardiograms, 6, minute walk test, and NT, proBNP levels. Right heart catheterization might be planned at 6, 12 months.
Are there any PAH subtypes that must not be treated with sotatercept?
Sotatercept is not indicated for PAH Groups 2, 5 and in cases of severe thrombocytopenia, pericardial effusion, or pregnancy, caution should be exercised.
What are the usual side effects in India?
Increasing hemoglobin, decreasing platelet count, reactions at the injection site, headache, diarrhea, and skin changes (e.g. telangiectasias) are among the possibilities. Blood tests are done to keep these under control.
Is sotatercept commercially available in India?
Sotatercept has received FDA approval in the US, but there are still some issues with its availability in India. It is advisable to contact your medical professional or local healthcare provider for the most recent information on how to get it.
How quickly will I be able to tell that sotatercept is working?
One can usually observe better walking distance and functional status within 12, 24 weeks and changes in haemodynamics by 6 months.
References:
Hoeper MM, et a1. STELLAR Trial. NEJM, 2023.
Rajagopal S, et a1. PULSAR Trial. NEJM Evidence, 2021.
HYPERION Trial. New England Journal ofMedicine, September 2025.
Mantoo MR, Majeed MW, Roy A. Efficacy and safety of sotatercept in pulmonary arterial hypertension: a systematic review and meta-analysis. Indian Heart Journal, January 2026.
Gomez Rojas O, et a1. Real-world performance of sotatercept in PAH with cardiopulmonary comorbidities. Pulmonary Circulation, 2025.
Pediatric heart failure may be defined as a state in which the heart fails in its primary role of circulating blood throughout the body. This might lead to serious complications if not detected early. Heart failure in children may not be immediately apparent until the condition worsens. This may be attributed to the early detection of the warning signs associated with the condition.
“Since pediatric or infant heart failure can be a subtly developing condition, it is crucial for parents and caregivers to be vigilant and monitor their child’s health for signs such as fatigue and rapid breathing,” statesDr. Prashant Bobhate, a leading pediatric cardiologist in Mumbai. “If appropriately managed and treated, children with heart failure can lead a normal and healthy life.
With over 12 years of experience in his field, Dr. Bobhate specializes in the management of pediatric heart failure in Mumbai, combining cutting-edge diagnostics with personalized treatment plans to ensure the best care for children at Kokilaben Dhirubhai Ambani Hospital. He is well-versed in dealing with both congenital and acquired conditions of theheart and is thus a professional of high repute for managing infant heart failure.
Wondering what pediatric heart failure is and how it affects children? Here’s an overview of this serious condition.
What is Pediatric Heart Failure?
Pediatric heart failure occurs when a child’s heart is unable to pump blood efficiently, leading to insufficient blood flow to organs and tissues. It can be caused bycongenital heart defects, infection, cardiomyopathy, or otherheart-related conditions. Symptoms of pediatric heart failure can vary but often include fatigue, rapid breathing, and swelling. Timely intervention is crucial, as untreated heart failure can lead to long-term complications or even life-threatening conditions.
Early detection and intervention are key to managing pediatric heart failure. Connect with an expert today for a comprehensive evaluation.
How to spot the early signs of pediatric heart failure? Let’s explore the top warning signs you should look out for in your child.
Warning Sign 1: Unexplained Fatigue and Weakness
Unexplained fatigue and weakness are some of the first signs of pediatric heart failure. When the body’s organs are not receiving oxygen and nutrients due to poor blood flow, symptoms such as fatigue, weakness, and low energy can occur. Children may have difficulty engaging in play or sports due to extreme tiredness.
Warning Sign 2: Rapid Breathing or Difficulty Breathing
Rapid breathing, or difficulty breathing, is a hallmark symptom of heart failure in children. When the heart is not pumping blood properly, fluid can accumulate in the lungs, leading to breathing difficulties. This may be accompanied by shortness of breath, especially during physical activity or while lying down. Babies may show signs of labored breathing or irregular chest movements.
Warning Sign 3: Swelling in the Legs, Abdomen, or Face
If the heart fails to pump the blood properly, it results in the accumulation of fluids within the body and hence it causes swelling, especially in the lower limbs, abdomen or face. This is known as edema and can be a sign of heart failure’s progression. Swelling around the abdomen may also cause discomfort and difficulty in feeding, particularly in infants.
Warning Sign 4: Poor Feeding and Weight Gain
In infants and toddlers, poor feeding and poor weight gain are common indicators that may be seen in cases of heart failure. Inability to pump blood by the heart implies that less blood reaches the digestive tract. Children with heart failure may tire easily when being fed. They fail to gain proper nutrition.
Warning Sign 5: Persistent Coughing or Wheezing
Fluid accumulation in the lungs in children with heart failure can cause coughing or wheezing. Fluid accumulation within the tissues of the lungs happens when the pumping function of the heart is compromised. The cough, in most cases, is dry, persistent, and exacerbated when one is physically active or when sleeping.
Unsure how pediatric cardiologists diagnose heart failure in children? Let’s dive into the diagnostic process and the tests involved.
How Pediatric Cardiologists Diagnose Heart Failure in Children
Clinical Evaluation
The diagnostic process begins with a thorough clinical evaluation, where the pediatric cardiologist reviews the child’s symptoms, medical history, and growth patterns. A physical examination focuses on identifying signs such as fatigue, swelling, or abnormal heart sounds.
Echocardiography (2D/3D)
A 2D echocardiogram provides a detailed view of the heart’s structure and function, identifying any structural heart defects and assessing how well the heart pumps blood.
Electrocardiogram
An ECG records the electrical activity of the heart, helping to identify abnormal heart rhythms that may be contributing to heart failure.
Chest X-ray and Blood Tests
Chest X-rays help detect fluid buildup in the lungs, while blood tests can reveal underlying causes such as infection, anemia, or kidney problems.
Wondering how pediatric heart failure is treated? Here are the treatment options that can help manage symptoms and improve quality of life.
Treatment and Management Options for Pediatric Heart Failure
Medications
Medications like diuretics, ACE inhibitors, and beta-blockers help reduce fluid buildup, lower blood pressure, and improve heart function.
Lifestyle Modifications
A balanced diet, managing salt intake, and adequate rest are necessary for managing heart failure in children.
Cardiac Surgery or Interventions
In severe cases, surgical interventions or catheter-based procedures may be needed to correct congenital heart defects or improve heart function.
Cardiac Rehabilitation
After stabilization, children may benefit from a rehabilitation program to improve heart strength and endurance.
Conclusion
Recognizing the warning signs of pediatric heart failure early can make all the difference. Timely intervention, appropriate treatment, and ongoing care are crucial to improving outcomes and ensuring a better quality of life.Dr. Prashant Bobhate’s approach combines advanced diagnostics, personalized treatment plans, and compassionate care to help children with heart failure live healthier, more active lives.
FAQs
Can children live a normal life with heart failure?
With early treatment and proper management, many children with heart failure lead active, fulfilling lives.
What is the treatment for pediatric heart failure?
Treatment includes medications like diuretics, ACE inhibitors, and beta-blockers, along with lifestyle adjustments and possible surgery.
What are the risks of pediatric heart failure?
Without treatment, pediatric heart failure can lead to severe complications, including heart failure, lung damage, and poor growth.
Can heart failure in children be prevented?
While some heart defects cannot be prevented, early detection and intervention can prevent complications and improve outcomes.
Is pediatric heart failure the same as adult heart failure?
No, pediatric heart failure often results from congenital defects, while adult heart failure is usually due to heart disease or lifestyle factors.
Heart disease in newborn babies can also cause death if it is not diagnosed and treated promptly. This condition of congenital heart disease usually passes unnoticed in the first few weeks or even months, so it is imperative for parents to know the signs of its occurrence in the infant. Early treatment of babies with heart disease can greatly change the prognosis for the newborn.
Dr. Prashant Bobhate, a highly experienced pediatric cardiologist in Mumbai, emphasizes that timely detection and treatment can significantly improve a neonate’s quality of life. “Neonatal heart disease is a major cause of morbidity, but early diagnosis and effective management can reduce long-term complications,” says Dr. Bobhate, who specializes in pediatric cardiology in Mumbai.
What Is Neonatal Heart Disease?
Congenital heart disease in the newborn refers to abnormalities in relation to the structure and function of the heart, which are present at birth.” This abnormality is also present in the heart, which was present at birth, and could include but not be limited to, the heart tissues, valves, and blood vessels. As stated above, congenital abnormalities, which include heart defects, could lead to severe complications if not identified early, which could lead to complications related to the blood reaching different parts of the body, including giving oxygenation. Examples of heart disease could include atrial septal defects, ventricular septal defects, and patent ductus arteriosus.
Early Signs and Symptoms of Heart Disease in Neonates
Recognizing the early signs of heart disease in neonates can be challenging, as many symptoms are subtle. However, some key indicators include:
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Bluish skin (cyanosis):
The skin may appear blue, especially around the lips or nails, indicating low oxygen levels in the blood.
E
Rapid breathing or difficulty breathing
Labored or rapid breathing may occur due to the heart’s inability to pump enough oxygenated blood to the lungs.
E
Poor feeding
Babies with heart disease may tire easily while feeding or struggle to gain weight.
E
Swelling
Edema, or swelling in the legs, abdomen, or face, may be seen in severe cases.
E
Irritability and fatigue
Persistent irritability, lethargy, and excessive tiredness could indicate heart strain.
Risk Factors for Heart Disease in Neonates
Certain factors increase the likelihood of a newborn developing heart disease, such as:
Family history of heart defects
Premature birth
Maternal conditions such as diabetes, high blood pressure, or infections during pregnancy
Chromosomal abnormalities like Down syndrome or Turner syndrome
Environmental factors like exposure to drugs, alcohol, or smoking during pregnancy
How Pediatric Cardiologists Diagnose Heart Disease in Neonates
Diagnosing heart disease in neonates requires a detailed evaluation, including:
Physical examination
A pediatric cardiologist listens for abnormal heart sounds or murmurs.
Echocardiogram (Echo)
An ultrasound of the heart helps visualize any abnormalities in heart structure or function.
Electrocardiogram (ECG)
Records electrical activity in the heart to detect arrhythmias or other issues.
Chest X-ray
Assesses the size and shape of the heart and lungs, helping identify fluid buildup or heart enlargement.
Treatment Options for Neonatal Heart Disease
Depending on the type of cardiovascular problem, treatment may be one of the following: Treatments for different types of cardiovascular disease include different
N
Medications
There may be some medications that can help with the symptoms, like diuretics for fluid retention or medications for heart function support.
N
Surgical procedure
There could be a need for surgery to repair the anatomical defects of the heart.
N
Catheterization
Less invasive techniques may also be adopted to fix or enlarge constricted blood vessels.
N
Continuous observation
There will be a need to visit the pediatric cardiologist regularly as a way of monitoring the heart conditions of the baby.
Prognosis and Long-Term Outcome in Infants Born with Heart Disease
The long-term prospects for infants with congenital heart disease are highly dependent on the level of heart disease present and the timing of the treatment for said disease. With early detection and treatment, many infants will lead a healthy,. However, for many infants, regular medical assistance, including possible surgeries, will be required.
Conclusion
It is important to identify the symptoms of heart disease within the newborns to ensure proper treatment on time. Although it may not be easy for the parents to notice the symptoms, collaboration with a pediatric cardiologist can greatly help them. Dr. Prashant Bobhate will help them with expert care for heart disease symptoms within the newborns, providing them with the best treatment necessary to ensure a healthy life.
If you suspect your baby may have heart disease, don’t wait. Contact Dr. Prashant Bobhate today for expert care and guidance.
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