Registry for patients with heart failure using pulmonary artery pressure monitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The HF2 Registry aims to collect comprehensive data on patients with heart failure who have been implanted with pulmonary artery pressure sensors. This observational, multi-center registry will gather demographic, clinical, laboratory, and hemodynamic information to enhance understanding of ambulatory hemodynamics monitoring and heart failure therapies. Patients will be recruited from heart failure clinics and will have the option to consent to participate in the registry, which will also facilitate future research opportunities based on the collected data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Pregnant women at the scheduled time of PA pressure sensor implant.
3. Patients unable or unwilling to have continuity of care in the heart failure clinic.

Where it's running

• Scripps Health
  La Jolla, California, United States Recruiting
• Indiana University
  Bloomington, Indiana, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Minneapolis Heart Institute Foundation/ Allina Health
  Minneapolis, Minnesota, United States Recruiting
• Saint Luke's Health System
  Kansas City, Missouri, United States Recruiting
• University of North Carolina/ Rex Hospital, Inc.
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Hirak Shah, MD — University of Kansas Medical Center
• Study coordinator: Kartik Munshi, MPH
• Email: kmunshi@kumc.edu
• Phone: 913-945-6445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.