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Telemonitoring to Treat Group 2 Pulmonary Hypertension | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Telemonitoring to Treat Group 2 Pulmonary Hypertension

Telemonitoring to Treat Group 2 Pulmonary Hypertension: A Personalized Approach

NCT04882774•Mardi Gomberg -Maitland MD, MSc

Summary

This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.

Detailed Description

This study hypothesizes that monitoring with ReDS-Pro System (ReDS), aggressive fluid management, and the CardioMEMS device (a 3-prong approach) will improve CpcPH (combined pre and post capillary pulmonary hypertension) hemodynamics (Total Pulmonary Resistance \[TPR\] and mPAP). For patients who continue to have an elevate pulmonary vascular resistance (TPR) at Week 16, with ReDS, aggressive fluid management, and the CardioMEMS device should allow successful titration of oral treprostinil by preventing titration related pulmonary edema and by improving hemodynamics, activity monitoring and six minute walk test (6MWT) after 16 weeks of therapy.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject voluntarily gives informed consent to participate in the study.
•The subject is 18 to 85 years of age (inclusive) at Baseline (i.e., date of providing written informed consent).
•The subject has a diagnosis of heart failure with a LVEF ≥45% by ECHO completed prior to randomization.
•The subject has a CardioMEMS device implanted as standard of care for a minimum of 30 days at Baseline.
•The subject has pulmonary function tests conducted within 12 months of Baseline or to confirm the following:
•1. Total lung capacity is ≥ 60% of the predicted value.
•2. Forced expiratory volume at 1 second (FEV1) is ≥50% of the predicted value.
•3. Diffusing capacity of the lungs for carbon monoxide (DLCO) is ≥ 32% of the predicted value (unadjusted or adjusted for alveolar volume).
•Subjects should be on maximally tolerated HFpEF therapies (e.g., ACE inhibitors, ARBs, beta blockers, SLG2 inhibitors) for ≥30 days prior to enrollment unless contraindicated. The exception is with changes of anticoagulants and/or diuretics; these medications should not be newly started or stopped within 14 days of enrollment and no healthcare provider prescribed dose change should occur within 7 days of enrollment, with the exception of the withholding of doses of anticoagulants for the conduct of the RHC when required.
•In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
+1 more criteria

Exclusion Criteria

•The subject is pregnant or lactating.
•In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH.
•The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation of therapy or inability to effectively titrate that therapy.
•The subject has received PAH therapies, including prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), nonprostanoid IP receptor agonist (selexipag), ERA, or soluble guanylate cyclase stimulator, within 30 days of enrollment. If the Investigator does not intend to keep a subject on their PDE5-I therapy, it must be stopped at least 30 days prior to enrollment. Intermittent use of a PDE5-I (≤3 times per week) to treat erectile dysfunction is permitted.
•The subject has been hospitalized for a cardiopulmonary indication within 30 days of randomization.
•The subject had a myocardial infarction within 90 days of enrollment.
•The subject had cardiac resynchronization therapy within 90 days of enrollment or anticipated resynchronization therapy during the study treatment period.
•The subject has liver function tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) greater than 3 times the upper limit of normal at Screening, clinically significant liver disease/dysfunction per Investigator's clinical judgement, known Child-Pugh Class C hepatic disease or noncirrhotic portal hypertension.
•The subject has uncontrolled systemic hypertension, defined as a systolic blood pressure \>160 mmHg or a diastolic blood pressure \>110 mmHg at Baseline on more than one occasion during screening.
•The subject has a systolic blood pressure \<100 mmHg at Baseline.
+10 more criteria

Locations (3)

George Washington University

Washington D.C., District of Columbia, United States

Ohio State University

Columbus, Ohio, United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

April 1, 2023

Primary Completion Date

April 1, 2025

Completion Date

April 1, 2027

Last Updated

June 6, 2023

Conditions

Pulmonary Hypertension Due to Left Heart Disease

Interventions

Treprostinil Diolamine

DRUG

Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

NCT04484675

Pulmonary Hypertension Due to Left Heart Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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