Overview

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure: Extent of Renal Damage

Status:
Withdrawn

Trial end date:
2018-05-01

Target enrollment:
0

Participant gender:
All

Summary

PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary study is to evaluate the rate of decline in renal function and frequency of development of acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Massachusetts General Hospital

Collaborators:

HealthCore-NERI
National Heart, Lung, and Blood Institute (NHLBI)
New England Research Institutes

Treatments:

Tadalafil

Criteria

Inclusion Criteria:

- All subjects eligible for enrollment into the PITCH-HF parent trial are eligible to
enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility
criteria)

Exclusion Criteria:

- Subjects who are not eligible for enrollment into the PITCH-HF parent trial may not
enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility
criteria)