Telemonitoring to Treat Group 2 Pulmonary Hypertension

NCT ID: NCT04882774

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2027-04-30

Brief 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.

Conditions

Pulmonary Hypertension Due to Left Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluid Management

Fluid management protocol only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral Treprostinil

Drug - oral treprostinil

Group Type: EXPERIMENTAL

Treprostinil Diolamine

Intervention Type: DRUG

Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID

Interventions

Treprostinil Diolamine

Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID

Intervention Type: DRUG

Eligibility Criteria

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.
• Subjects on chronic medications (e.g. inhaled corticosteroids, long-acting beta2-adrenergic agonist, long-acting muscarinic antagonists, combination inhaled drugs, anti-inflammatory drugs, oral/parenteral corticosteroids, or biologic agents) for any underlying respiratory condition must be on a stable dose for ≥30 days prior to randomization.

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.
• The subject has a resting heart rate >110 beats per minute at Baseline.
• The subject has sarcoidosis or cardiac amyloidosis.
• The subject has a known history of any LVEF less than 40% by ECHO within 3 years of enrollment. Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition (e.g., atrial fibrillation) is allowed.
• The subject has hemodynamically significant valvular heart disease as determined by the Investigator, including:

1. Greater than mild aortic and/or mitral stenosis

2. Severe mitral and/or aortic regurgitation (>Grade 3)

• The subject has a body mass index >45 kg/m2.
• The subject has any musculoskeletal disorder (e.g., arthritis affecting the lower limbs, recent hip or knee joint replacement, artificial leg), or has any other condition that would likely be the primary limit to ambulation as opposed to the disease under study.
• The subject has end-stage renal disease requiring/receiving dialysis.
• The subject has used any investigational drug/device, or participated in any investigational study, within 30 days prior to the Baseline visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: collaborator

Mardi Gomberg -Maitland MD, MSc

OTHER

Sponsor Role: lead

Responsible Party

Mardi Gomberg -Maitland MD, MSc

Director, Pulmonary Hypertension Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mardi Gomberg-Maitland, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Raymond Benza, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Countries

United States

Other Identifiers

RECAP001

Identifier Type: -

Identifier Source: org_study_id