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Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)

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ClinicalTrials.gov Identifier: NCT03043651
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Associated With HFpEF Drug: Oral Treprostinil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral treprostinil
Sustained-Release tablets for three times daily (TID) administration
Drug: Oral Treprostinil
Sustained-release oral tablets for TID administration
Other Name: Treprostinil diethanolamine




Primary Outcome Measures :
  1. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with treatment-related adverse events [ Time Frame: Baseline through study completion, up to approximately 8 years ]
  2. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by clinical laboratory parameters [ Time Frame: Baseline through study completion, up to approximately 8 years ]
  3. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with heart failure signs and symptoms [ Time Frame: Baseline through study completion, up to approximately 8 years ]

Secondary Outcome Measures :
  1. Effect of Continued Long-term Oral Treprostinil Therapy on the 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.

  2. Effect of Continued Long-term Oral Treprostinil Therapy on the Borg Dyspnea Score [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).

  3. Effect of Continued Long-term Oral Treprostinil Therapy on World Health Organization (WHO) Functional Class [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The WHO functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).

  4. Effect of Continued Long-term Oral Treprostinil Therapy on the N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to Weeks 24 and 48 ]
    The NT-proBNP is a biomarker associated with changes in right heart morphology and function.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study.

Exclusion Criteria

  • The subject is pregnant or lactating.
  • The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
  • The subject developed a concurrent illness or condition during Study TDE HF 301, which, in the opinion of the Investigator, would represent a risk to the subject's overall health if they enrolled in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043651


Contacts
Contact: David B Yehle, RPh 919 485-8350 dyehle@unither.com
Contact: Louis Holdstock, PhD 919 485-8350 lholdstock@unither.com

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Sponsors and Collaborators
United Therapeutics

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03043651     History of Changes
Other Study ID Numbers: TDE-HF-302
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United Therapeutics:
Pulmonary Hypertension
HFpEF
6-Minute Walk Test
Oral Treprostinil

Additional relevant MeSH terms:
Hypertension
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents