Clinical Trial Trends: Rare Cardiovascular

Rare cardiovascular diseases are fairly common; some 5% of people in the world have one of these conditions. However, when you look at those diseases individually, the incidence is often rare. Researchers have identified more than 6,000 rare diseases that impact the heart and/or circulatory system—so, it can be difficult to receive a diagnosis. Not all clinicians are well-versed in every rare cardiovascular condition. Further, while the majority of these diseases are present at a young age, some manifest much later. 

In this article, we start by looking at the current trends in rare Cardiovascular research using data from Citeline. We go on to examine Precision’s experience in this therapeutic area. 

Understanding the Rare Cardiovascular Clinical Trial Landscape  

Conducting research on rare cardiovascular conditions also has certain challenges. Aside from the issues one might expect in rare disease (like patient recruitment for a disease with an extremely low incidence rate), cardiovascular disease as a therapeutic area is vulnerable to study design issues and bias. Ethical considerations and monitoring are also of significant importance. 

Rare Cardiovascular Clinical Trials by Status 

Looking at the number of current rare cardiovascular trials compared to the total number, approximately 14% are current, meaning they are open or planned. 

Rare Cardiovascular Trials by Status 

Citeline Trialtrove^® – 18JUN2024 

Rare Cardiovascular Trials by Start Date 

The number of planned and ongoing rare cardiovascular clinical trials shows an upward trend.  

Planned & Ongoing Rare Cardiovascular Trials by Start Date 

Citeline Trialtrove^® – 18JUN2024 

Rare Cardiovascular Trials by Country  

The current landscape of rare cardiovascular trials includes 90 countries. The United States and China are by far the most common. Each country boasts over 200 current clinical trials in this therapeutic area. 

Planned & Ongoing Rare Cardiovascular Trials by Site Country—Top 10

Citeline Trialtrove^® – 18JUN2024 

Rare Cardiovascular Trials by Indication  

Looking at specific indications, most rare cardiovascular trials include patients that have Hemostasis/Hemophilia, Cardiomyopathy, or Pulmonary Hypertension. 

Planned & Ongoing Rare Cardiovascular Trials by Indication—Top 10 

Chart Caption: Citeline Trialtrove^® – 18JUN2024 

Rare Cardiovascular Trials by Phase  

Current rare cardiovascular trials are fairly divided amongst early phase and late phase research, with the highest percentage in Phase 4, suggesting new treatments are on the horizon. 

Planned & Ongoing Rare Cardiovascular Trials by Phase 

Citeline Trialtrove^® – 18JUN2024 

Precision's Expertise in Rare Cardiovascular Research  

At Precision, we have worked on 37 clinical trials that included rare cardiovascular indications.  

Rare Cardiovascular Trial Starts  

We have started 7 rare cardiovascular trials since 2019. Here is a breakdown of our trials in this therapeutic area by start date.  

Precision for Medicine's Rare Cardiovascular Trials by Start Date 

Citeline Trialtrove^® – 18JUN2024 

Precision's Reach in Rare Cardiovascular Research  

Precision’s work in rare cardiovascular research has spanned 59 countries. 

Precision for Medicine's Rare Cardiovascular Trials by Site Country 

Citeline Trialtrove^® – 18JUN2024 

Trials by Phase  

In the field of rare therapeutic research, Precision has done only slightly more early phase research than late phase. Most of our experience is in Phase 2 or Phase 3 clinical trials, but we have done some Phase 1 rare cardiovascular research. 

Precision for Medicine's Rare Cardiovascular Trials by Phase 

Citeline Trialtrove^® – 18JUN2024 

Precision's Experience by Indication 

Precision has conducted a range of trials in the therapeutic area of rare cardiovascular conditions. Most of our work has been in Pulmonary Hypertension, but we are also experienced in Cardiomyopathy, Congestive Heart Failure, and Hereditary Angioedema (HAE). 

Precision for Medicine's Rare Cardiovascular Trials by Therapeutic Class 

Chart Caption: Citeline Trialtrove^® – 18JUN2024 

The Precision Difference 

Rare cardiovascular research is characterized by small patient populations and genetic complexity. These factors can make patient recruitment challenging, but that’s just the beginning. Regulatory hurdles, site selection, study design and endpoint selection—these factors all contribute to greater complexity in conducting rare cardiovascular clinical trials. Choose a CRO that can handle those issues with precision. 

Precision understands the nuances of conducting clinical trials in this therapeutic area and can help guide your drug development program from Phase 1 to regulatory submission.