NCT04610788|Completed
Cardiac Assessment by PV Loop in IPAH and Scleroderma PAH
CALIPSO
Understanding Right Ventricular Heart Failure in Scleroderma and Idiopathic Pulmonary Arterial Hypertension
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CALIPSO
Understanding Right Ventricular Heart Failure in Scleroderma and Idiopathic Pulmonary Arterial Hypertension
Sponsor study identifier
Secondary identifiers
observational
43
1 country
1
Study Start
April 15, 2019
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Study Completion
December 31, 2025
Actual (reported)This observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated PAH) and a weak heart muscle (heart failure). The study will also help the investigators understand why people with PAH from an unknown cause (called idiopathic PAH, or IPAH) can also develop a weakened heart muscle. The response of the right side of the heart or right ventricle (RV) to standard PAH therapy in scleroderma-associated PAH and in IPAH will be assessed. Blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. People with scleroderma-associated PAH or idiopathic cause (IPAH) who need a right heart catheterization may join this study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2019
Actual (reported)October 26, 2020
Actual (reported)November 2, 2020
Actual (reported)December 31, 2025
Actual (reported)December 31, 2025
Actual (reported)Right Ventricular Function as assessed by RHC
Assessed on the clinical RHC as normal, moderately reduced, or severely reduced.
Baseline
Change in pulmonary vascular resistance
Assessed as improved or decreased after 6 months by comparing the change in pulmonary vascular resistance in Wood units on the clinical RHC.
Baseline and 6months
Change in arterial elastance
Assessed as improved or decreased after 6 months by comparing the change in arterial elastance in pressure volume (PV) loops.
Baseline and 6 months
Change in myofilament contractility
Assessed as Normal or Abnormal after studying the collected samples in lab. Abnormal can be either reduced or increased; i.e. hyper- or hypo-contractile.
up to 4 years
Change in calcium sensitivity
Assessed as either increased- or decreased- sensitivity after 6 months, by studying the collected samples in lab.
up to 4 years
Number of genes expressed
up to 4 years
Number of proteins expressed
up to 4 years
Scleroderma patients referred for a clinically indicated right heart catheterization (RHC).
Presumed/known IPAH patients referred for a clinically indicated right heart catheterization (RHC).
Patients 18 years or older with clinically diagnosed scleroderma or presumed/known idiopathic pulmonary hypertension.
Johns Hopkins
Baltimore, Maryland, 21287, United States
Cardiac biopsy, 4 teaspoons of blood
Paul Hassoun, MD
Johns Hopkins University
43 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2020
First Posted
November 2, 2020
Study Start
April 15, 2019
Actual (reported)Yoga Adjunct for Scleroderma
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2025
Actual (reported)Study Completion
December 31, 2025
Actual (reported)Last Updated
January 9, 2026
Record last verified: 2026-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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